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Changes in objectively measured sleep after a multidisciplinary lifestyle intervention in children with abdominal obesity: A randomized trial.
Catalán-Lambán, A, Ojeda-Rodríguez, A, Marti Del Moral, A, Azcona-Sanjulian, C
Sleep medicine. 2023;109:252-260
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The main factors that contribute to obesity are genetics, excessive energy intake, decreased physical activity, and sedentarism. Sleep duration, sleep timing and chronotype have also recently been recognised as possible risk factors for obesity in children. The aim of this study was to assess the effectiveness of an intervention (usual care vs. intervention group) on sleep quality and its relationship with changes in biochemical and metabolic syndrome related anthropometric parameters. This study was a randomised controlled trial. The multidisciplinary intervention consisted of a two-year program that comprised a 2-month intensive phase with individual and group sessions and a follow-up period at 12 and 24 months. Subjects were randomly assigned to the usual care or intervention group at a ratio of 1:3. Results showed that a lifestyle intervention improved most sleep parameters in children and adolescents with abdominal obesity. In fact, the lifestyle intervention showed a reduction in anthropometric indexes and several biochemical parameters, and improved sleep quality at 2, 12, and 24 months of follow-up. Decreasing sleep latency, awakenings duration and wakefulness after sleep onset (WASO) also accompanied improved sleep efficiency. Authors conclude that their findings add to the growing body of research on the relationship between sleep and metabolic health outcomes in children, emphasizing the need to consider multiple dimensions of sleep beyond just sleep duration.
Abstract
BACKGROUND/OBJECTIVE childhood obesity and sleep disorders have a well-established cross-sectional association, but lifestyle interventions' effects on sleep quality remain under-researched. This study aimed to evaluate the sleep quality of 122 participants (7-16 years) with abdominal obesity after a 2-year necessary lifestyle intervention. PATIENTS/METHODS participants were assigned to either the intervention group (moderate hypocaloric Mediterranean Diet) or the usual care group (standard recommendations on a healthy diet). Sleep was objectively assessed using triaxial accelerometry, and sleep parameters analyzed included latency, efficiency, wake after sleep onset, total time in bed, total sleep time, number of awakenings, and awakening duration. RESULTS AND CONCLUSIONS the results showed that the intervention group significantly improved sleep latency at 12 and 24 months and improved sleep efficiency at 2 and 12 months, compared to the usual care group. Wake after sleep onset and the number of awakenings were significantly reduced at 24 months in the intervention group. Wake after sleep onset and leptin levels were positively associated in all participants. Total time in bed was inversely associated with triglycerides and metabolic score, and total sleep time was inversely associated with leptin, triglycerides, and metabolic score after the 2-month intervention. Triglyceride levels were inversely associated with total time in bed and total sleep time at one year, while the metabolic score was directly associated with wake after sleep onset and the number of awakenings and inversely associated with efficiency. In conclusion, the multidisciplinary intervention in children and adolescents with abdominal obesity reduced anthropometric parameters and improved sleep habits.
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The effects of time-restricted eating and weight loss on bone metabolism and health: a 6-month randomized controlled trial.
Papageorgiou, M, Biver, E, Mareschal, J, Phillips, NE, Hemmer, A, Biolley, E, Schwab, N, Manoogian, ENC, Gonzalez Rodriguez, E, Aeberli, D, et al
Obesity (Silver Spring, Md.). 2023;31 Suppl 1:85-95
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Intermittent fasting (IF) involves an alternation of abstinence and consumption of food and caloric beverages over a cycle of hours to days. Time-restricted feeding (in animals) or eating (TRE in humans) is a form of IF that entails restricting eating within a window of 4 to 12 hours per 24-hour cycle and prolonging the time spent in the fasted state to realign eating-fasting patterns with circadian rhythms. The aim of this study was to explore the impact of a 6-month randomised controlled trial of TRE versus standard dietary advice (SDA, active control arm) on bone metabolism and health in a population with at least one component of the metabolic syndrome. This study is a secondary analysis of an open-label 6-month randomised controlled trial in which participants who ate within a time interval > 14 hours per 24-hour cycle (n=54) were randomised to TRE or SDA (active control) with a 1:1 allocation ratio. A total of 42 participants (76% women) with available bone turnover markers and/or bone mass measurements were included in this study. Results show that there weren’t any detrimental effects on bone health outcomes i.e. bone metabolism or bone loss after 6 months of TRE. Additionally, weight loss following a period of TRE might be associated with small bone-sparing effects compared with SDA. Authors conclude that future studies of longer duration (>6 months) assessing multiple bone phenotypes are required in order to confirm the study’s findings and explore the effects of various TRE regimens particularly among individuals at risk for bone fragility such as postmenopausal women and the elderly.
Abstract
OBJECTIVE This study explored the impact of time-restricted eating (TRE) versus standard dietary advice (SDA) on bone health. METHODS Adults with ≥1 component of metabolic syndrome were randomized to TRE (ad libitum eating within 12 hours) or SDA (food pyramid brochure). Bone turnover markers and bone mineral content/density by dual energy x-ray absorptiometry were assessed at baseline and 6-month follow-up. Statistical analyses were performed in the total population and by weight loss response. RESULTS In the total population (n = 42, 76% women, median age 47 years [IQR: 31-52]), there were no between-group differences (TRE vs. SDA) in any bone parameter. Among weight loss responders (≥0.6 kg weight loss), the bone resorption marker β-carboxyterminal telopeptide of type I collagen tended to decrease after TRE but increase after SDA (between-group differences p = 0.041), whereas changes in the bone formation marker procollagen type I N-propeptide did not differ between groups. Total body bone mineral content decreased after SDA (p = 0.028) but remained unchanged after TRE (p = 0.31) in weight loss responders (between-group differences p = 0.028). Among nonresponders (<0.6 kg weight loss), there were no between-group differences in bone outcomes. CONCLUSIONS TRE had no detrimental impact on bone health, whereas, when weight loss occurred, it was associated with some bone-sparing effects compared with SDA.
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Impact of α-Linolenic Acid, the Vegetable ω-3 Fatty Acid, on Cardiovascular Disease and Cognition.
Sala-Vila, A, Fleming, J, Kris-Etherton, P, Ros, E
Advances in nutrition (Bethesda, Md.). 2022;13(5):1584-1602
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α-Linolenic acid (ALA) is an omega-3 fatty acid found in seeds and nuts such as flaxseeds, chia seeds, and walnuts and in oils such as canola oil, soybean oil, flaxseed oil and walnut oil. It has been shown to reduce the risk of coronary heart disease and cardiovascular disease. This meta-analysis examined the results of various studies, including epidemiologic studies, randomized controlled trials, and systematic reviews, to evaluate the beneficial effects of ALA in improving cognitive function and reducing the risk of cardiovascular disease and coronary heart disease. The included studies showed a correlation between ALA intake and a decreased risk of cardiovascular disease and coronary heart disease, possibly due to ALA's anti-inflammatory properties, as well as its ability to reduce total cholesterol, LDL cholesterol, triglycerides, and blood pressure. The analysis also found that ALA intake may reduce the risk of type 2 diabetes and cognitive impairment. Healthcare professionals can leverage the findings of this analysis to educate individuals about the benefits of dietary ALA in improving cardiovascular and cognitive outcomes. However, further studies are necessary to establish definitive conclusions and determine therapeutic dosage.
Abstract
Given the evidence of the health benefits of plant-based diets and long-chain n-3 (ω-3) fatty acids, there is keen interest in better understanding the role of α-linolenic acid (ALA), a plant-derived n-3 fatty acid, on cardiometabolic diseases and cognition. There is increasing evidence for ALA largely based on its major food sources (i.e., walnuts and flaxseed); however, this lags behind our understanding of long-chain n-3 fatty acids. Meta-analyses of observational studies have shown that increasing dietary ALA is associated with a 10% lower risk of total cardiovascular disease and a 20% reduced risk of fatal coronary heart disease. Three randomized controlled trials (RCTs) [AlphaOmega trial, Prevención con Dieta Mediterránea (PREDIMED) trial, and Lyon Diet Heart Study] all showed benefits of diets high in ALA on cardiovascular-related outcomes, but the AlphaOmega trial, designed to specifically evaluate ALA effects, only showed a trend for benefit. RCTs have shown that dietary ALA reduced total cholesterol, LDL cholesterol, triglycerides, and blood pressure, and epidemiologic studies and some trials also have shown an anti-inflammatory effect of ALA, which collectively account for, in part, the cardiovascular benefits of ALA. A meta-analysis reported a trend toward diabetes risk reduction with both dietary and biomarker ALA. For metabolic syndrome and obesity, the evidence for ALA benefits is inconclusive. The role of ALA in cognition is in the early stages but shows promising evidence of counteracting cognitive impairment. Much has been learned about the health benefits of ALA and with additional research we will be better positioned to make strong evidence-based dietary recommendations for the reduction of many chronic diseases.
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Effects of curcumin and/or coenzyme Q10 supplementation on metabolic control in subjects with metabolic syndrome: a randomized clinical trial.
Sangouni, AA, Taghdir, M, Mirahmadi, J, Sepandi, M, Parastouei, K
Nutrition journal. 2022;21(1):62
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Metabolic syndrome (MetS) is a cluster of metabolic disorders such as hyperlipidaemia, hypertension, hyperglycaemia, insulin resistance, and abdominal obesity. MetS is associated with cardiovascular disease (CVD), type 2 diabetes mellitus and non-alcoholic fatty liver disease. The aim of this study was to investigate the effects of curcumin and/or coenzyme Q10 supplementation on metabolic syndrome components in subjects with MetS. This study is a 2×2 factorial, randomised, double-blinded, placebo-controlled study which was conducted for 12 weeks. Eighty-eight subjects were randomly assigned into four groups. All subjects completed the trial. Results show that curcumin supplementation improves lipid profile, but it does not have any effect on body composition, hypertension and fasting plasma glucose. However, supplementation with coenzyme Q10 as well as curcumin plus coenzyme Q10 did not show any significant effects on lipid profile, body composition, hypertension and fasting plasma glucose. Authors conclude that curcumin supplementation (especially by its effects on dyslipidaemia) is more effective than coenzyme Q10 as well as the combination of curcumin and coenzyme Q10 in the management of MetS. However, curcumin, coenzyme Q10 and their combination have no effect on body composition, hypertension and glycaemic control.
Abstract
BACKGROUND Metabolic syndrome (MetS) as a cluster of conditions including hyperlipidemia, hypertension, hyperglycemia, insulin resistance, and abdominal obesity is linked to cardiovascular diseases and type 2 diabetes. Evidence suggested that intake of curcumin and coenzyme Q10 may have therapeutic effects in the management of MetS. AIMS We investigated the effects of curcumin and/or coenzyme Q10 supplementation on metabolic syndrome components including systolic blood pressure (SBP), diastolic blood pressure (DBP), waist circumference (WC), triglyceride (TG), high density lipoprotein-cholesterol (HDL-c) and fasting plasma glucose (FPG) as primary outcomes, and total cholesterol (TC), low density lipoprotein-cholesterol (LDL-c) and body mass index (BMI) as secondary outcomes in subjects with MetS. METHODS In this 2 × 2 factorial, randomized, double-blinded, placebo-controlled study, 88 subjects with MetS were randomly assigned into four groups including curcumin plus placebo (CP), or coenzyme Q10 plus placebo (QP), or curcumin plus coenzyme Q10 (CQ), or double placebo (DP) for 12 weeks. RESULTS The CP group compared with the three other groups showed a significant reduction in HDL-c (P = 0.001), TG (P < 0.001), TC (P < 0.001), and LDL-c (P < 0.001). No significant differences were seen between the four groups in terms of SBP, DBP, FPG, WC, BMI and weight. CONCLUSION Curcumin improved dyslipidemia, but had no effect on body composition, hypertension and glycemic control. Furthermore, coenzyme Q10 as well as the combination of curcumin and coenzyme Q10 showed no therapeutic effects in subjects with MetS. The trial was registered on 09/21/2018 at the Iranian clinical trials website (IRCT20180201038585N2), URL: https://www.irct.ir/trial/32518 .
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Effects of inulin supplementation on body composition and metabolic outcomes in children with obesity.
Visuthranukul, C, Chamni, S, Kwanbunbumpen, T, Saengpanit, P, Chongpison, Y, Tepaamorndech, S, Panichsillaphakit, E, Uaariyapanichkul, J, Nonpat, N, Chomtho, S
Scientific reports. 2022;12(1):13014
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The prevalence of overweight and obesity among children and adolescents has risen dramatically. Overweight and obese children are at risk of developing co-morbidities such as type 2 diabetes mellitus, hypertension, dyslipidaemia, metabolic syndrome, non-alcohol fatty liver disease and premature cardiovascular diseases. Furthermore, obese children are highly prone to become obese adults. The aim of this study was to determine the effects of prebiotic (as inulin) supplementation on body weight, adiposity, and metabolic profiles in obese Thai children. This study is a randomised double-blinded placebo-controlled trial. Participants (n=165) were randomly allocated to 3 groups: inulin, placebo, and dietary fibre advice group. Results show that the intensive behavioural modification and frequent follow-up are effective strategies to reduce body mass index and adiposity in obese children. Furthermore, even though inulin supplementation did not demonstrate considerable effect on adiposity and metabolic outcomes, it can increase fat-free mass in these children. Authors conclude that further research regarding the change of gut microbiota composition and their metabolites are needed to determine inulin’s impact on host microbe interaction in obese paediatric population.
Abstract
Inulin might improve body composition in obese children. We aimed to determine the effects of inulin supplementation on body composition and metabolic outcomes in obese children. A randomized, double-blinded placebo-controlled study was conducted in obese Thai children aged 7-15 years. Participants were assigned to 3 treatment groups for 6 months: 13 g of extracted inulin powder from Thai Jerusalem artichoke, isocaloric maltodextrin, and dietary fiber advice groups. Body composition was assessed by bioelectrical impedance analysis. One-hundred and fifty-five children completed the study (mean age 10.4 ± 2.2 years, BMI z-score 3.2 ± 1.0, 59% male). The drop-out rate was 6%. The inulin extract yielded more than 90% compliance without significant gastrointestinal side effects. All three groups demonstrated a significant decrease in BMI z-score, fat mass index (FMI), and trunk FMI, but the differences between groups were not observed. Fat-free mass index significantly increased only in the inulin group (16.18 ± 1.90 vs. 16.38 ± 1.98 kg/m2, P = 0.009). There were no significant differences in the metabolic profiles between groups. Despite showing no substantial effect on adiposity, inulin may increase fat-free mass in obese children. Further research in the change of gut microbiota composition is needed to determine inulin's impact on host-microbe interaction in pediatric obesity.
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Eight-hour time-restricted feeding improves endocrine and metabolic profiles in women with anovulatory polycystic ovary syndrome.
Li, C, Xing, C, Zhang, J, Zhao, H, Shi, W, He, B
Journal of translational medicine. 2021;19(1):148
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Polycystic ovary syndrome (PCOS) is one of the most common reproductive endocrine and metabolic disorders that affects up to 10% women of childbearing age. The aim of this study was to explore the effects of time-restricted feeding (TRF) on menstruation, gonadal and metabolic parameters in women with anovulatory PCOS and propose a basis for its inclusion in the treatment of PCOS. This study is a 6-week trial with 2 consecutive periods: (1) 1-week baseline weight stabilization period; and (2) 5-week TRF period. Fifteen subjects were included in the study whose age varied between 18 and 31 years. Results show that five weeks of TRF improved menstruation, gonadal profiles, body weight, body mass index, body composition profiles, hyperinsulinemia and insulin resistance profiles, decreasing chronic inflammation markers and increasing insulin growth factor –1 [hormone]. Authors conclude that TRF may be suitable for PCOS women with appropriate counselling and patient management.
Abstract
BACKGROUND Time-restricted feeding (TRF) is a form of intermittent fasting, which is beneficial for weight loss and cardiometabolic health. Polycystic ovary syndrome (PCOS) is one of the most common reproductive endocrine and metabolic diseases affecting women of childbearing age. It is associated with an increased prevalence of metabolic syndrome, cardiovascular diseases and type 2 diabetes. The effects of TRF on PCOS patients remains undefined, here we investigated the impact of TRF on women with anovulatory PCOS. METHODS Eighteen PCOS women aged between 18 and 31 with anovulation participated in a 6-week trial which were divided into two consecutive periods: (1) 1-week baseline weight stabilization period and (2) 5-week TRF period. Fifteen participants completed the study. Changes in body weight, body mass index (BMI), Waist-to-Hip Ratio, skeletal muscle mass, body fat mass (BFM), body fat percentage (BF%), visceral fat area (VFA), luteinizing hormone (LH), follicle-stimulating hormone (FSH), LH/FSH, total testosterone (TT), sex hormone-binding globulin (SHBG), free androgen index (FAI), fasting glucose, fasting insulin (FINS), homeostasis model assessment-insulin resistance (HOMA-IR), area under the curve (AUC) for insulin (AUCIns), area under the curve (AUC) for glucose (AUCGlu), AUCIns/AUCGlu Ratio, lipids, uric acid, alanine aminotransferase (ALT), aspartate aminotransferase, high-sensitivity C-reactive protein (hsCRP), insulin-like growth factor (IGF-1), menstrual cycle and eating behaviors were evaluated. RESULTS Significant changes in body weight, BMI, BFM, BF%, VFA, TT, SHBG, FAI, FINS, HOMA-IR, AUCIns, AUCIns/AUCGlu Ratio, ALT, hsCRP and IGF-1 were found after the TRF period. An improvement in menstrual cycle irregularity was detected in 73.3% (11/15) patients. CONCLUSION The diet of TRF may be beneficial to anovulatory PCOS on weight loss especially reducing body fat, improving menstruation, hyperandrogenemia, insulin resistance and chronic inflammation. Trial registration Clinicaltrial.gov, NCT04580433, registered October 8, 2020, https://clinicaltrials.gov/ct2/show/NCT04580433.
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Effect of Vitamin D Supplementation on Obesity-Induced Insulin Resistance: A Double-Blind, Randomized, Placebo-Controlled Trial.
Cefalo, CMA, Conte, C, Sorice, GP, Moffa, S, Sun, VA, Cinti, F, Salomone, E, Muscogiuri, G, Brocchi, AAG, Pontecorvi, A, et al
Obesity (Silver Spring, Md.). 2018;26(4):651-657
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Vitamin D concentration has been inversely associated with impaired glucose regulation, insulin resistance and risk of metabolic dysfunction. The aim of the study was to evaluate whether Vitamin D supplementation could improve insulin sensitivity in patients with a high risk of diabetes. The study is a randomised, double-blind, placebo-controlled trial. The participants with obesity were supplemented with Vitamin D or placebo on top of a hypocaloric diet. Results indicate that Vitamin D supplementation combined with weight loss is linked with a significant improvement in insulin sensitivity in vitamin D deficient participants with obesity.
Abstract
OBJECTIVE The aim was to investigate whether vitamin D supplementation, combined with a hypocaloric diet, could have an independent effect on insulin sensitivity in subjects with both overweight and hypovitaminosis D. Changes from baseline in anthropometric parameters, body composition, glucose tolerance, and insulin secretion were considered as secondary outcomes. METHODS Eighteen volunteers who were nondiabetic and vitamin D deficient and had BMI > 25 kg/m2 were randomized (1:1) in a double-blind manner to a hypocaloric diet + either oral cholecalciferol at 25,000 IU/wk or placebo for 3 months. Hyperinsulinemic-euglycemic clamp to measure insulin sensitivity was performed at baseline and after intervention. RESULTS Body weight in both groups decreased significantly (-7.5% in the vitamin D group and -10% in the placebo group; P < 0.05 for both), with no between-group differences. Serum 25-hydroxyvitamin D levels in the vitamin D group increased considerably (from 36.7 ± 13.2 nmol/L to 74.8 ± 18.7 nmol/L; P < 0.001). Insulin sensitivity in the vitamin D group improved (from 4.6 ± 2.0 to 6.9 ± 3.3 mg·kg-1 ·min-1 ; P < 0.001), whereas no changes were observed in the placebo group (from 4.9 ± 1.1 to 5.1 ± 0.3 mg·kg-1 ·min-1 ; P = 0.84). CONCLUSIONS Cholecalciferol supplementation, combined with a weight loss program, significantly improves insulin sensitivity in healthy subjects with obesity and might represent a personalized approach for insulin-resistant subjects with obesity.
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Improvement of Nonalcoholic Fatty Liver Disease With Carnitine-Orotate Complex in Type 2 Diabetes (CORONA): A Randomized Controlled Trial.
Bae, JC, Lee, WY, Yoon, KH, Park, JY, Son, HS, Han, KA, Lee, KW, Woo, JT, Ju, YC, Lee, WJ, et al
Diabetes care. 2015;38(7):1245-52
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Non-alcoholic fatty liver disease (NAFLD) is recognized as the hepatic component of metabolic syndrome, and it is associated with insulin resistance independent of obesity and other metabolic components. Carnitine is a modulator of mitochondrial free fatty acid transport and oxidation, and several studies have demonstrated the antioxidant activity of carnitine in hepatocytes. The aim of this study was to evaluate the effects of carnitine-orotate complex in patients with NAFLD and diabetes. This study is a multicentre, randomised, double-blind, placebo-controlled trial. Patients were randomly assigned to receive carnitine-orotate complex or placebo during the 12-week treatment period. Results show that treatment with carnitine-orotate complex improves hepatic steatosis in patients with diabetes and NAFLD, and has a beneficial effect on glucose metabolism, particularly in relation to improvement of hepatic steatosis. Authors conclude that further studies using more advanced magnetic resonance imaging and liver histology as an end point are needed to assess its efficacy in NAFLD.
Abstract
OBJECTIVE We aimed to evaluate the effects of carnitine-orotate complex in patients with nonalcoholic fatty liver disease (NAFLD) and diabetes. RESEARCH DESIGN AND METHODS Eight hospitals in Korea participated in this randomized, controlled, double-blind trial of patients with diabetes and NAFLD. Seventy-eight patients were randomly assigned in a 1:1 ratio to receive carnitine-orotate complex (824 mg, three times daily) or matching placebo. The primary study outcome was decline in alanine aminotransferase (ALT) to the normal range. Secondary study outcomes were change in ALT, radiological hepatic steatosis, parameters for anthropometry, liver function, lipid profiles, and glycemic control. Hepatic steatosis was assessed using Hounsfield units on noncontrast computed tomography (CT) imaging with hepatic attenuation. RESULTS After 12 weeks of treatment, compared with placebo group, carnitine-orotate complex-treated participants had a significantly higher rate of normalization of serum ALT level (17.9% vs. 89.7%, P < 0.001). On hepatic CT analysis, participants treated with carnitine-orotate complex showed an increased liver attenuation index (0.74 ± 8.05 vs. 6.21 ± 8.96, P < 0.008). A significant decrease in HbA1c was observed in the carnitine-orotate complex group (-0.33 ± 0.82% [-3.6 ± 9.0 mmol/mol], P = 0.007), but no significant change was seen in the placebo group. CONCLUSIONS Treatment with carnitine-orotate complex improves serum ALT and may improve hepatic steatosis as assessed by CT in patients with diabetes and NAFLD. Further studies using more advanced magnetic resonance imaging and liver histology as an end point are needed to assess its efficacy in NAFLD.
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L-carnitine ameliorated fasting-induced fatigue, hunger, and metabolic abnormalities in patients with metabolic syndrome: a randomized controlled study.
Zhang, JJ, Wu, ZB, Cai, YJ, Ke, B, Huang, YJ, Qiu, CP, Yang, YB, Shi, LY, Qin, J
Nutrition journal. 2014;13:110
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Metabolic syndrome increases the risk of heart disease and diabetes. Modified fasting therapy, such as a very-low-calorie diet is considered an effective way to tackle obesity and metabolic syndrome. When fasting, calorie restriction may cause fatigue and intense hunger, which may tempt individuals to stop fasting. L-Carnitine is an amino acid that transports long-chain fatty acids to mitochondria and helps them be oxidised to produce energy. L-Carnitine intravenous therapy is more bioavailable, better absorbed, and cleared than oral supplementation. This randomised, single-blinded, placebo-controlled pilot study included 30 individuals with metabolic syndrome who were randomly assigned to receive either 4 g/day of intravenous L-carnitine or saline for seven days to evaluate the effect of L-Carnitine on fatigue, hunger, body mass, lipid profile, and other CHD risk factors during a modified fasting period. The L-Carnitine group showed a significant reduction in waist-hip ratio, body mass, serum insulin levels, γ-glutamyltransferase, mental and physical fatigue, fatigue severity, weight loss, and greater reduction in waist circumference, total cholesterol and hunger when compared to the control group. Healthcare professionals can use the results of this study to understand the beneficial effects of L-Carnitine administration during modified fasting therapy in reducing weight, metabolic risk factors, hunger and fatigue. Long-term studies are required to confirm the benefits of L-carnitine.
Abstract
BACKGROUND The present study aimed to determine that whether L-carnitine infusion could ameliorate fasting-induced adverse effects and improve outcomes. METHOD In this 7-day, randomized, single-blind, placebo-controlled, pilot study, 15 metabolic syndrome (MetS) patients (11/4 F/M; age 46.9 ± 9.14 years; body mass index [BMI] 28.2 ± 1.8 kg/m2) were in the L-carnitine group (LC) and 15 (10/5 F/M; age 46.8 ± 10.9 years; BMI 27.1 ± 2.3 kg/m2) were in the control group (CT). All participants underwent a 5-day modified fasting therapy introduced with 2-day moderate calorie restriction. Patients in the LC group received 4 g/day of intravenous L-carnitine, while patients in the CT group were injected with saline. Blood pressure (BP), anthropometric characteristics, markers of liver function, metabolic indices (plasma glucose, lipid profiles, uric acid, free fatty acid and insulin) and hypersensitivity C-reactive protein were measured. Perceived hunger was recorded daily by self-rating visual analogue scales. Fatigue was evaluated by Wessely and Powell scores. RESULTS In contrast to the CT group, total cholesterol, alanine aminotransferase, systolic and diastolic BP did not change significantly in the LC group after prolonged fasting. There were significant differences in weight loss (LC -4.6 ± 0.9 vs. CT -3.2 ± 1.1 kg, P = 0.03), and waist circumference (LC -5.0 ± 2.2 vs. CT -1.7 ± 1.16 cm, P < 0.001), waist hip ratio (LC -0.023 ± 0.017 vs. CT 0.012 ± 0.01, P < 0.001), insulin concentration (LC -9.9 ± 3.58 vs. CT -6.32 ± 3.44 µU/mL, P = 0.046), and γ-glutamyltransferase concentration (LC -7.07 ± 6.82 vs. CT -2.07 ± 4.18, P = 0.024). Perceived hunger scores were significantly increased (P < 0.05) in the CT group during starvation, which was alleviated with L-carnitine administration in the LC group. Physical fatigue (LC -3.2 ± 3.17 vs. CT 1.8 ± 2.04, P < 0.001) and fatigue severity (LC -11.6 ± 8.38 vs. CT 8.18 ± 7.32, P < 0.001) were significantly reduced in the LC group but were aggravated in the CT group. CONCLUSION Intravenous L-carnitine can ameliorate fasting-induced hunger, fatigue, cholesterol abnormalities and hepatic metabolic changes and facilitate fasting-induced weight loss in MetS patients. TRIAL REGISTRATION ChiCTR-TNRC-12002835.