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Participant experiences in the Diabetes REmission Clinical Trial (DiRECT).
Rehackova, L, Rodrigues, AM, Thom, G, Brosnahan, N, Barnes, AC, McCombie, L, Leslie, WS, Zhyzhneuskaya, S, Peters, C, Adamson, AJ, et al
Diabetic medicine : a journal of the British Diabetic Association. 2022;(1):e14689
Abstract
INTRODUCTION The Diabetes REmission Clinical Trial (DiRECT) has shown that sustained remission of type 2 diabetes in primary care is achievable through weight loss using total diet replacement (TDR) with continued behavioural support. Understanding participants' experiences can help optimise the intervention, support implementation into healthcare, and understand the process of behaviour change. METHODS Thirty-four DiRECT participants were recruited into this embedded qualitative evaluation study. In-person and telephone interviews were conducted before the TDR; at week 6-8 of the TDR; 2 weeks into food reintroduction (FR); and at 1 year, to learn about participant experiences with the programme. Transcribed narratives were analysed thematically, and we used interpretation to develop overarching themes. RESULTS Initiation of the TDR and transition to FR were challenging and required increased behavioural support. In general, adhering to TDR proved easier than the participants had anticipated. Some participants chose the optional extension of TDR. Rapid weight loss and changes in diabetes markers provided ongoing motivation. Further weight loss, behavioural support and occasional use of TDR facilitated weight loss maintenance (WLM). A process of behaviour adaptation to change following regime disruption was identified in three stages: (1) expectations of the new, (2) overcoming difficulties with adherence, and (3) acceptance of continuous effort and establishment of routines. CONCLUSIONS The DiRECT intervention was acceptable and regularity, continuity, and tailoring of behavioural support was instrumental in its implementation in primary care. The adaptation process accounts for some of the individual variability of experiences with the intervention and highlights the need for programme flexibility.
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Insulin/IGF-1 Signaling Is Downregulated in Barrett's Esophagus Patients Undergoing a Moderate Calorie and Protein Restriction Program: A Randomized 2-Year Trial.
Arcidiacono, D, Zaramella, A, Fabris, F, Sánchez-Rodríguez, R, Nucci, D, Fassan, M, Nardi, M, Benna, C, Cristofori, C, Morbin, T, et al
Nutrients. 2021;(10)
Abstract
Obesity and associated insulin resistance (Ins-R) have been identified as important risk factors for esophageal adenocarcinoma development. Elevated calories and protein consumption are also associated with Ins-R and glucose intolerance. We investigated the effect of a 24-month moderate calorie and protein restriction program on overweight or obese patients affected by Barrett's esophagus (BE), as no similar dietary approach has been attempted to date in this disease context. Anthropometric parameters, levels of serum analytes related to obesity and Ins-R, and the esophageal insulin/IGF-1 signaling pathway were analyzed. This study is registered with ClinicalTrials.gov, number NCT03813381. Insulin, C-peptide, IGF-1, IGF-binding protein 3 (IGFBP3), adipokines, and esophageal expression of the main proteins involved in insulin/IGF-1 signal transduction were quantified using Luminex-XMAP® technology in 46 patients who followed the restriction program (IA) and in 54 controls (CA). Body mass index and waist circumference significantly decreased in 76.1% of IA and 35.2% of CA. IGF-1 levels were reduced in 71.7% of IA and 51.8% of CA. The simultaneous reduction of glycaemia, IGF-1, the IGF-1/IGFBP3 ratio, and the improvement in weight loss-dependent insulin sensitivity, were associated with the downregulation of the insulin/IGF-1 signal on BE tissue. The proposed intervention program was an effective approach to counteract obesity-associated cancer risk factors. The improvement in metabolic condition resulted in a downregulation of the ERK-mediated mitogenic signal in 43.5% of patients, probably affecting the molecular mechanism driving adenocarcinoma development in BE lesions.
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Branched Chain Amino Acid Supplementation to a Hypocaloric Diet Does Not Affect Resting Metabolic Rate but Increases Postprandial Fat Oxidation Response in Overweight and Obese Adults after Weight Loss Intervention.
Ooi, DSQ, Ling, JQR, Ong, FY, Tai, ES, Henry, CJ, Leow, MKS, Khoo, EYH, Tan, CS, Chong, MFF, Khoo, CM, et al
Nutrients. 2021;(12)
Abstract
BACKGROUND Branched chain amino acids (BCAA) supplementation is reported to aid in lean mass preservation, which may in turn minimize the reduction in resting metabolic rate (RMR) during weight loss. Our study aimed to examine the effect of BCAA supplementation to a hypocaloric diet on RMR and substrate utilization during a weight loss intervention. METHODS A total of 111 Chinese subjects comprising 55 males and 56 females aged 21 to 45 years old with BMI between 25 and 36 kg/m2 were randomized into three hypocaloric diet groups: (1) standard-protein (14%) with placebo (CT), (2) standard-protein with BCAA, and (3) high-protein (27%) with placebo. Indirect calorimetry was used to measure RMR, carbohydrate, and fat oxidation before and after 16 weeks of dietary intervention. RESULTS RMR was reduced from 1600 ± 270 kcal/day to 1500 ± 264 kcal/day (p < 0.0005) after weight loss, but no significant differences in the change of RMR, respiratory quotient, and percentage of fat and carbohydrate oxidation were observed among the three diet groups. Subjects with BCAA supplementation had an increased postprandial fat (p = 0.021) and decreased postprandial carbohydrate (p = 0.044) oxidation responses compared to the CT group after dietary intervention. CONCLUSIONS BCAA-supplemented standard-protein diet did not significantly attenuate reduction of RMR compared to standard-protein and high-protein diets. However, the postprandial fat oxidation response increased after BCAA-supplemented weight loss intervention.
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Short-Term Pre-Operative Protein Caloric Restriction in Elective Vascular Surgery Patients: A Randomized Clinical Trial.
Kip, P, Sluiter, TJ, Moore, JK, Hart, A, Ruske, J, O'Leary, J, Jung, J, Tao, M, MacArthur, MR, Heindel, P, et al
Nutrients. 2021;(11)
Abstract
(1) Background: Vascular surgery operations are hampered by high failure rates and frequent occurrence of peri-operative cardiovascular complications. In pre-clinical studies, pre-operative restriction of proteins and/or calories (PCR) has been shown to limit ischemia-reperfusion damage, slow intimal hyperplasia, and improve metabolic fitness. However, whether these dietary regimens are feasible and safe in the vascular surgery patient population remains unknown. (2) Methods: We performed a randomized controlled trial in patients scheduled for any elective open vascular procedure. Participants were randomized in a 3:2 ratio to either four days of outpatient pre-operative PCR (30% calorie, 70% protein restriction) or their regular ad-libitum diet. Blood was drawn at baseline, pre-operative, and post-operative day 1 timepoints. A leukocyte subset flow cytometry panel was performed at these timepoints. Subcutaneous/perivascular adipose tissue was sampled and analyzed. Follow-up was one year post-op. (3) Results: 19 patients were enrolled, of whom 11 completed the study. No diet-related reasons for non-completion were reported, and there was no intervention group crossover. The PCR diet induced weight loss and BMI decrease without malnutrition. Insulin sensitivity was improved after four days of PCR (p = 0.05). Between diet groups, there were similar rates of re-intervention, wound infection, and cardiovascular complications. Leukocyte populations were maintained after four days of PCR. (4) Conclusions: Pre-operative PCR is safe and feasible in elective vascular surgery patients.
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Effects of synbiotic supplementation on serum adiponectin and inflammation status of overweight and obese breast cancer survivors: a randomized, triple-blind, placebo-controlled trial.
Raji Lahiji, M, Zarrati, M, Najafi, S, Yazdani, B, Cheshmazar, E, Razmpoosh, E, Janani, L, Raji Lahiji, M, Shidfar, F
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021;(7):4147-4157
Abstract
PURPOSE Adipokines and inflammatory factors can affect breast cancer (BC) prognosis and recurrence among breast cancer survivors (BCSs). This study was to evaluate the effects of synbiotic supplementation along with a low-calorie diet on some recurrence-related factors such as adiponectin, tumor necrosis factor-alpha (TNF-α), and high-sensitivity C-reactive protein (hs-CRP) among obese and overweight BCSs. METHODS We performed a randomized, triple-blind, placebo-controlled clinical trial among 76 overweight or obese postmenopausal women with a history of hormone-receptor-positive BC. Participants were randomly divided into 2 groups to intake either 109 CFU/day synbiotic supplement or placebo (n = 38 each group) for 8 weeks. All participants were given a low-calorie diet program. The primary outcome was serum concentration of adiponectin which was measured at baseline and after 8 weeks. RESULTS Compared with the placebo, synbiotic intake significantly increased adiponectin (+ 13.58 (10.08, 18.17) vs. - 0.42 (- 2.90, 1.98) μg/ml; P < 0.001). In addition, synbiotic supplementation resulted in significant reduction in TNF-α levels (- 17.09 (- 32.05, - 13.60) vs. 0.20 (- 3.97, 2.00) ng/L; P < 0.001) and hs-CRP levels (- 1.14 (- 1.90, - 0.88 vs. - 0.06 (- 0.38, 0.15) mg/L; P < 0.001) compared with the placebo. CONCLUSIONS In conclusion, 8-week synbiotic consumption by overweight and obese postmenopausal BCSs had beneficial effects on adiponectin, TNF-α, and hs-CRP. TRIAL REGISTRATION IRCT, IRCT20091114002709N49. Registered 18 May 2018, http://www.irct.ir : IRCT20091114002709N49.
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The Feasibility of Using Computrition Software for Nutrition Research-A Pilot Study.
Millar, CL, Cohen, A, Juraschek, SP, Foley, A, Shtivelman, M, Mukamal, KJ, Sahni, S
Nutrients. 2021;(2)
Abstract
We evaluated the feasibility of using Computrition to design and implement a low vs. typical sodium meal plan intervention for older adults. Dietitians used Computrition to design a 7-day meal plan with three caloric levels (≤1750, 2000, ≥2250 kcals/day) and two sodium densities (low = 0.9 mg/kcal; n = 11 or typical = 2 mg/kcal; n = 9). Feasibility was determined by post-hoc definitions of effectiveness, sodium compliance, palatability of diet, sustainability, and safety. Given the low number of participants in one of the three calorie groups, the higher calorie groups were combined. Thus, comparisons are between low vs. typical meal plans at two calorie levels (≤1750 or ≥2000 kcals/day). Overall, regardless of the calorie group, the meal plans created with Computrition were effective in reaching the targeted sodium density and were safe for participants. Furthermore, individuals appeared to be equally compliant and reported similar palatability across meal plans. However, one of the three criteria for the sustainability definition was not met. In conclusion, we successfully used Computrition to design low and typical sodium meal plans that were effective, compliable, and safe. Future studies of older adults in similar settings should focus on improving the palatability of the meal plans and scaling this protocol to larger studies in older adults.
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Grape seed extract supplementation along with a restricted-calorie diet improves cardiovascular risk factors in obese or overweight adult individuals: A randomized, placebo-controlled trial.
Yousefi, R, Parandoosh, M, Khorsandi, H, Hosseinzadeh, N, Madani Tonekaboni, M, Saidpour, A, Babaei, H, Ghorbani, A
Phytotherapy research : PTR. 2021;(2):987-995
Abstract
Grape seed extract (GSE) is a flavonoid-rich supplement, recently discussed as a potential moderator of inflammation and obesity. In this study, we aimed to investigate the effects of GSE supplementation along with a restricted-calorie diet (RCD), on changes in blood lipid profile, visceral adiposity index (VAI), and atherogenic index of plasma (AIP). We designed a randomized, double-blinded, placebo-controlled clinical trial. Forty obese or overweight individuals (25 ≤ body mass index < 40 kg/m2 ) were randomly assigned to receive GSE (300 mg/day) or placebo, plus RCD, for 12 weeks. We studied the anthropometric measures, biochemical biomarkers and dietary intake within the study timelines. Levels of high-density lipoprotein cholesterol (HDL-C) and HDL-C/low-density lipoprotein cholesterol (LDL-C) significantly increased in the GSE group as compared with the placebo group at week 12 (p = .03 and .008, respectively, adjusted for age, sex, energy and saturated fatty acid intake). We also observed a significant reduction in LDL-C following GSE supplementation in comparison to placebo (adjusted for age, sex and energy intake, p = .04). VAI, AIP, total cholesterol and triglyceride significantly decreased in the GSE group compared with the baseline (p = .04, .02, .01, and .02, respectively). GSE supplementation may have a modulatory role in improving blood lipid profile in obese or overweight individuals, when accompanied by RCD.
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Eucaloric Balanced Diet Improved Objective Sleep in Adolescents with Obesity.
Saidi, O, Rochette, E, Del Sordo, G, Doré, É, Merlin, É, Walrand, S, Duché, P
Nutrients. 2021;(10)
Abstract
BACKGROUND A better understanding of the influence of energy balance on sleep in adolescents, particularly those with obesity, could help develop strategies to optimize sleep in these populations. The purpose of this study was to investigate sleep under ad libitum-vs-controlled diets adjusted to energy requirement (eucaloric) among adolescents with obesity and their normal weight controls. METHODS Twenty-eight male adolescents aged between 12 and 15 years, n = 14 adolescents with obesity (OB: BMI ≥ 90th centile) and n = 14 normal weight age matched controls (NW), completed an experimental protocol comprising ad libitum or eucaloric meals for three days, in random order. During the third night of each condition, they underwent in home polysomnography (PSG). RESULTS An interaction effect of energy intake (EI) was detected (p < 0.001). EI was higher during ad libitum compared to the eucaloric condition (p < 0.001) and in OB compared to NW (p < 0.001) in the absence of any substantial modification to macronutrient proportions. Analyses of energy intake distribution throughout the day showed a significant interaction with both a condition and group effect during lunch and dinner. Sleep improvements were noted in OB group during the eucaloric condition compared to ad libitum with reduced sleep onset latency and N1 stage. Sleep improvements were correlated to reduced EI, especially during the evening meal. CONCLUSION Simply adjusting dietary intake to energy requirement and reducing the energy proportion of the evening meal could have therapeutic effects on sleep in adolescents with obesity. However, positive energy balance alone cannot justify worsened sleep among adolescents with obesity compared to normal weight counterparts.
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Higher unacylated ghrelin and insulin sensitivity following dietary restriction and weight loss in obese humans.
Barazzoni, R, Gortan Cappellari, G, Zanetti, M, Klaus, KA, Semolic, A, Johnson, ML, Nair, KS
Clinical nutrition (Edinburgh, Scotland). 2021;(2):638-644
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Abstract
BACKGROUND & AIMS Unacylated ghrelin (UnAG) modulates insulin sensitivity. Low plasma UnAG occurs in obesity and potentially contributes to obesity-associated insulin resistance. We hypothesized that improvements in insulin sensitivity in obese people induced by moderate caloric restriction (CR) may be paralleled and at least in part explained by concurrent increases in UnAG levels. METHODS 20 general community obese people were randomly assigned to 16-week CR (n = 11) or control diet (n = 9). We investigated the impact of CR on the interaction between insulin sensitivity changes [area under the curve (AUCg) of glucose infusion to maintain euglycemia during hyperinsulinemic-euglycemic clamp] and plasma total (TotalG), acylated (AG) and Unacylated ghrelin (UnAG). Plasma pro-inflammatory tumor necrosis factor alpha (TNFα) and anti-inflammatory interleukin-10 (IL-10) were also measured since changes in inflammation may contribute to UnAG activities. RESULTS CR reduced BMI and increased insulin sensitivity (p < 0.05). TotalG and UnAG but not AG increased in CR but not in Control (p < 0.05). Il-10 and IL-10/TNFα ratio also increased in CR (p < 0.05). Changes in UnAG were positively associated with changes in AUCg in all subjects (n = 20; p < 0.01) also after adjustment for treatment and changes in BMI and cytokines. CONCLUSIONS Caloric restriction modifies circulating ghrelin profile with selective increase in unacylated hormone in obese individuals. The current study supports the hypothesis that higher unacylated ghrelin contributes to improvements in insulin sensitivity following diet-induced weight loss in human obesity.
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Lower Energy-Dense Ready Meal Consumption Affects Self-Reported Appetite Ratings with No Effect on Subsequent Food Intake in Women.
Hannon, SC, Hillier, SE, Thondre, PS, Clegg, ME
Nutrients. 2021;(12)
Abstract
Slimming World (SW), a commercial weight management organisation, has designed a range of low energy-dense ready meals (LEDRMs) in line with their programme. This randomised crossover study compared commercially available equicaloric ready meals differing in energy density on satiety and food intake. It was hypothesised that the LEDRM would reduce energy intake (EI) whilst increasing fullness and reducing hunger compared to higher energy-dense ready meal (HEDRM, control). A total of 26 female participants (aged 18-65 years; body mass index of 28.8 ± 3.0 kg·m-2) attended two test days. The participants ate a standard breakfast, and four hours later, ate either a LEDRM or HEDRM at lunch. EI was measured four hours later at an ad libitum tea. Satiety measurements were recorded throughout the day using visual analogue scales and a weighed food diary was completed for the remainder of the day. The results revealed that the LEDRM reduced hunger and increased fullness (both p < 0.001). There was no difference in EI at the evening meal between the ready meals (p > 0.05), however, during the whole LEDRM testing day, the participants consumed significantly less fat (7.1%) and saturated fat (3.6%) (both p < 0.01), but significantly more carbohydrates, sugars, fibre, protein, and salt (all p < 0.01). The results indicate that the participants felt more satiated after consuming ready meals of the same energy content but larger portion size. Despite no significant difference in short-term EI between the ready meals, the results indicated that the LEDRM produced beneficial subjective satiety responses and, therefore, can help to improve the nutritional content of meals i.e., reduce saturated fat consumption.