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A Randomized Double-Blind, Cross-Over Trial of very Low-Calorie Diet in Overweight Migraine Patients: A Possible Role for Ketones?
Di Lorenzo, C, Pinto, A, Ienca, R, Coppola, G, Sirianni, G, Di Lorenzo, G, Parisi, V, Serrao, M, Spagnoli, A, Vestri, A, et al
Nutrients. 2019;11(8)
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The ketogenic diet (KD) constitutes high-fat, adequate protein, and low-carbohydrate, and has been proven to be efficacious for the treatment of drug-resistant epilepsy. Recently, KD showed promising results for treating other neurological conditions. The aim of this study was to analyse the effects of very low-calorie ketogenic diets (VLCKDs) in overweight episodic migraine patients during a weight-loss intervention. This study is a double-blind cross-over design randomised trial (of five phases). Participants eligible for trial participation were overweight/obese adults, aged 18 to 65 years, who had at least 12 months’ history of migraines with or without aura. Subjects alternated randomly between a very low-calorie ketogenic diet and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. Results indicate that a 4-week period VLCKD, despite inducing similar weight loss and glycaemic profile, was significantly more effective than VLCnKD in preventing migraine attacks, as evidenced by a decrease in the frequency of migraine days and attacks, and a greater than 50% response rate. Authors conclude that VLCKD is effective for rapid, short-term improvement of migraines in overweight patients, while VLCnKD is not.
Abstract
Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in which subjects alternated randomly between a very low-calorie ketogenic diet (VLCKD) and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. In a nutritional program, 35 overweight obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order (VLCKD-VLCnKD or VLCnKD-VLCD). The primary outcome measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Secondary outcome measures were 50% responder rate for migraine days, reduction of monthly migraine attacks, abortive drug intake and body mass index (BMI) change. Only data from the intention-to-treat cohort (n = 35) will be presented. Patients who dropped out (n = 6) were considered as treatment failures. Regarding the primary outcome, during the VLCKD patients experienced -3.73 (95% CI: -5.31, -2.15) migraine days respect to VLCnKD (p < 0.0001). The 50% responder rate for migraine days was 74.28% (26/35 patients) during the VLCKD period, but only 8.57% (3/35 patients) during VLCnKD. Migraine attacks decreased by -3.02 (95% CI: -4.15, -1.88) during VLCKD respect to VLCnKD (p < 0.00001). There were no differences in the change of acute anti-migraine drug consumption (p = 0.112) and BMI (p = 0.354) between the 2 diets. A VLCKD has a preventive effect in overweight episodic migraine patients that appears within 1 month, suggesting that ketogenesis may be a useful therapeutic strategy for migraines.
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Mixed Nut Consumption May Improve Cardiovascular Disease Risk Factors in Overweight and Obese Adults.
Abbaspour, N, Roberts, T, Hooshmand, S, Kern, M, Hong, MY
Nutrients. 2019;11(7)
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A large portion of heart disease cases are preventable through lifestyle and dietary modifications. The aim of this study was to assess the effect of daily intake of 42.5 g of mixed nuts on cardiovascular disease (CVD) risk factors in overweight and obese adults. This study is an 8-week randomized, parallel-arm, controlled trial with two isocaloric treatment groups of mixed-nuts and pretzels. A total of 54 participants (22 females and 32 males) were recruited. Results indicate that supplementation of 42.5 g/day of mixed nuts for 8 weeks decreases body weight, insulin, blood glucose, and lactate dehydrogenase [enzyme] levels compared with consumption of an isocaloric amount of pretzels. Additionally, consumption of pretzels increased low-density lipoprotein cholesterol and triglyceride levels while decreasing high-density lipoprotein cholesterol. Authors conclude that the incorporation of mixed nuts into a usual diet improves some risk factors for CVD.
Abstract
Emerging research indicates that nuts are a source of health-promoting compounds demonstrating cardioprotective benefits. However, most studies have assessed the effect of single nuts rather than a nut mixture. The objective of this study was, therefore, to examine the effect of mixed-nut consumption on cardiovascular disease (CVD) risk factors in overweight and obese adults. In a randomized, parallel-arm, controlled trial, 48 participants consumed isocaloric (250 kcal) amounts of pretzels or mixed-nuts. Body weight (BW) (p = 0.024), BMI (p = 0.043), and insulin levels (p = 0.032) were significantly lower in the nut group compared to the pretzel group. Mixed-nut consumption also significantly reduced glucose (p = 0.04) and insulin (p = 0.032) levels after 4 and 8 weeks compared to baseline, respectively. Lactate dehydrogenase of the nut group was significantly lower than the pretzel group (p = 0.002). No significant differences were detected between groups for triglycerides, LDL-C, and HDL-C. However, pretzel consumption increased triglycerides (p = 0.048) from 4 weeks to 8 weeks. Moreover, LDL-C increased (p = 0.038) while HDL-C transiently decreased (p = 0.044) from baseline to 4 weeks. No significant lipid changes were detected within the nut group. Our results suggest that supplementing the diet with mixed-nuts could improve CVD risk factors by improving BW and glucose regulation in comparison to a common carbohydrate-rich snack without promoting the negative effects on lipids detected with pretzels.
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Health Biomarkers in Adults Are More Closely Linked to Diet Quality Attributes Than to Plant-Based Diet Categorization.
Mayra, S, Ugarte, N, Johnston, CS
Nutrients. 2019;11(6)
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Plant-based diets rich in fruits, vegetables, whole grains, nuts, and legumes are consistently linked to reduced risk for chronic disease, improved cognition, and longevity. The aim of the study was to examine the diet quality and blood metabolites of vegetarian and omnivore adults to determine adherence to plant-based diets compared to high-quality eating patterns. The study is a cross-sectional investigation. Thirty-three participants (17 vegetarians: 3 men/14 women; 16 omnivores: 3 men/13 women) aged between 18 and 65 years were enrolled for the study. Results indicate the health biomarkers did not differ between vegetarians and omnivores matched for gender, age, and adiposity. However, when participants were regrouped by low-quality versus high-quality diets, data suggests that several common health biomarkers are more closely aligned with diet quality attributes than with plant-based diet categorisation. Authors conclude that healthcare practitioners should emphasize diet quality in their messages to their clients and discuss the importance of eating whole, minimally processed foods with less added fat and sugars.
Abstract
Although plant-based diets are promoted for healthy outcomes, these diets are not synonymous with high-quality diets. Plant-based diets can include highly processed, less healthful foods, including savory snacks, pastries, and sugary fruit drinks. This cross-sectional study examined the diet quality of vegetarian and omnivorous adults, matched for gender, age, and adiposity, and related diet quality to standard health biomarkers. Diet quality was assessed using the Rapid Eating and Activity Assessment for Participants Short Version questionnaire. Participants (17 vegetarians and 16 omnivores; 28.2 ± 8.9 years; 22.5 ± 2.7 kg/m2) were non-smokers and healthy by self-report. The median duration of adherence to the vegetarian diet was 27 months. Physical activity level and diet quality did not differ significantly between diet groups. Moreover, health biomarkers did not differ by diet groups. When participants were regrouped by low versus high diet quality, health biomarkers differed significantly between groups for fasting insulin, HOMA-IR, triglyceride (TG)/HDL ratio, and blood folate, with more favorable levels in the group with high diet quality. These data suggest that health biomarkers more closely align with diet quality attributes than with plant-based diet categorization. Thus, messaging focused on healthy diet attributes may lead to better health outcomes than the simple promotion of plant-based diets.
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Anti-Inflammatory Effects of a Vegan Diet Versus the American Heart Association-Recommended Diet in Coronary Artery Disease Trial.
Shah, B, Newman, JD, Woolf, K, Ganguzza, L, Guo, Y, Allen, N, Zhong, J, Fisher, EA, Slater, J
Journal of the American Heart Association. 2018;7(23):e011367
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Inflammation plays a central role in the progression of atherosclerosis and is associated with adverse cardiovascular events. The aim of this study was to determine the effects of a vegan versus American Heart Association (AHA)-recommended diet on high-sensitivity C-reactive protein (hsCRP) [a type of protein found in blood plasma], as well as other markers of inflammation, glucometabolic markers, and lipid profiles in patients with established coronary artery disease (CAD) on guideline-directed medical therapy. This study is a prospective, randomized, open-label, blinded end point study design. The active study duration was 8 weeks, with an interim visit at 4 weeks and a final visit at 8 weeks. Results show: - a significantly greater reduction in hsCRP with a vegan versus AHA-recommended diet in patients with established CAD on guideline-directed medical therapy. - that the degree of weight loss, as measured by both body mass index and waist circumference, did not significantly differ between the 2 diet groups. - that markers of glycaemic control and lipid profiles, overall, also did not significantly differ in the vegan diet group when compared with the AHA-recommended diet group. Authors conclude that in patients with CAD and an elevated hsCRP, despite guideline-directed medical therapy, a vegan diet may be considered to further lower the parameters of inflammation.
Abstract
Background Dietary interventions may play a role in secondary cardiovascular prevention. hsCRP (High-sensitivity C-reactive protein) is a marker of risk for major adverse cardiovascular outcomes in coronary artery disease. Methods and Results The open-label, blinded end-point, EVADE CAD (Effects of a Vegan Versus the American Heart Association-Recommended Diet in Coronary Artery Disease) trial randomized participants (n=100) with coronary artery disease to 8 weeks of a vegan or American Heart Association-recommended diet with provision of groceries, tools to measure dietary intake, and dietary counseling. The primary end point was high-sensitivity C-reactive protein. A linear regression model compared end points after 8 weeks of a vegan versus American Heart Association diet and adjusted for baseline concentration of the end point. Significance levels for the primary and secondary end points were set at 0.05 and 0.0015, respectively. A vegan diet resulted in a significant 32% lower high-sensitivity C-reactive protein (β, 0.68, 95% confidence interval [0.49-0.94]; P=0.02) when compared with the American Heart Association diet. Results were consistent after adjustment for age, race, baseline waist circumference, diabetes mellitus, and prior myocardial infarction (adjusted β, 0.67 [0.47-0.94], P=0.02). The degree of reduction in body mass index and waist circumference did not significantly differ between the 2 diet groups (adjusted β, 0.99 [0.97-1.00], P=0.10; and adjusted β, 1.00 [0.98-1.01], P=0.66, respectively). There were also no significant differences in markers of glycemic control between the 2 diet groups. There was a nonsignificant 13% reduction in low-density lipoprotein cholesterol with the vegan diet when compared with the American Heart Association diet (adjusted β, 0.87 [0.78-0.97], P=0.01). There were no significant differences in other lipid parameters. Conclusions In patients with coronary artery disease on guideline-directed medical therapy, a vegan diet may be considered to lower high-sensitivity C-reactive protein as a risk marker of adverse outcomes. Clinical Trial Registration URL http://www.clinicaltrials.gov . Unique identifier: NCT 02135939.
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Effect of intermittent vs. daily calorie restriction on changes in weight and patient-reported outcomes in people with multiple sclerosis.
Fitzgerald, KC, Vizthum, D, Henry-Barron, B, Schweitzer, A, Cassard, SD, Kossoff, E, Hartman, AL, Kapogiannis, D, Sullivan, P, Baer, DJ, et al
Multiple sclerosis and related disorders. 2018;23:33-39
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Multiple sclerosis (MS) is a disease of the central nervous system. Dietary modification is emerging as a safe intervention to potentially modify disease course. The main aim of this study was to assess the safety and feasibility of an intermittent fasting diet in people with MS. Secondary outcomes explored the effects of calorie restriction (CR) diets on body weight and anthropometric characteristics as well as on patient-reported outcomes including fatigue, sleep and mood. The study is a pilot randomised controlled feeding study of three different types of diets. Each participant (n=36) was randomized to 1 of 3 diets: a control diet (placebo), a daily CR diet and intermittent CR diet. Results indicate that daily CR diet was associated with marginally greater weight loss than the intermittent CR diet. Both CR diets were associated with trends toward improvements in cardiometabolic outcomes. Furthermore, CR diets were associated with in improvements in emotional well-being. Authors conclude that CR and weight loss represent interventions for clinically relevant symptoms due to MS, such as emotional well-being, without adding meaningful risks or adverse outcomes.
Abstract
An intermittent fasting or calorie restriction diet has favorable effects in the mouse forms of multiple sclerosis (MS) and may provide additional anti-inflammatory and neuroprotective advantages beyond benefits obtained from weight loss alone. We conducted a pilot randomized controlled feeding study in 36 people with MS to assess safety and feasibility of different types of calorie restriction (CR) diets and assess their effects on weight and patient reported outcomes in people with MS. Patients were randomized to receive 1 of 3 diets for 8 weeks: daily CR diet (22% daily reduction in energy needs), intermittent CR diet (75% reduction in energy needs, 2 days/week; 0% reduction, 5 days/week), or a weight-stable diet (0% reduction in energy needs, 7 days/week). Of the 36 patients enrolled, 31 (86%) completed the trial; no significant adverse events occurred. Participants randomized to CR diets lost a median 3.4 kg (interquartile range [IQR]: -2.4, -4.0). Changes in weight did not differ significantly by type of CR diet, although participants randomized to daily CR tended to have greater weight loss (daily CR: -3.6 kg [IQR: -3.0, -4.1] vs. intermittent CR: -3.0 kg [IQR: -1.95, -4.1]; P = 0.15). Adherence to study diets differed significantly between intermittent CR vs. daily CR, with lesser adherence observed for intermittent CR (P = 0.002). Randomization to either CR diet was associated with significant improvements in emotional well-being/depression scores relative to control, with an average 8-week increase of 1.69 points (95% CI: 0.72, 2.66). CR diets are a safe/feasible way to achieve weight loss in people with MS and may be associated with improved emotional health.
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The Effect of Low-Carbohydrate Diet on Glycemic Control in Patients with Type 2 Diabetes Mellitus.
Wang, LL, Wang, Q, Hong, Y, Ojo, O, Jiang, Q, Hou, YY, Huang, YH, Wang, XH
Nutrients. 2018;10(6)
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Dietary intervention is a strategy to manage diabetes mellitus, as it can reduce the burden on islet cells and thus improve blood glucose levels, lipid profiles, and cognitive status. The aim of the study was to find out the effectiveness of the ‘six-point formula’ and the effects of a low-fat diet and low-carbohydrate diet on hyperglycaemia. The study is a prospective, single-blind randomized controlled trial which recruited 56 participants with type 2 diabetes mellitus. The participants were randomly allocated to receive either a low-fat diet or a low-carbohydrate diet. Results show that HbA1c levels (the average blood glucose levels in the last 2 – 3 months) in low-carbohydrate diet decreased significantly compared to the low-fat diet. The body mass index and the total cholesterol levels of the participants following the low-carbohydrate diet also decreased. Authors conclude that a low-carbohydrate diet can improve blood glucose, regulate blood lipids, reduce body mass index and decrease insulin doses more than a low-fat diet in Chinese patients with type 2 diabetes mellitus.
Abstract
OBJECTIVE In China, a low-fat diet (LFD) is mainly recommended to help improve blood glucose levels in patients with type 2 diabetes mellitus (T2DM). However, a low-carbohydrate diet (LCD) has been shown to be effective in improving blood glucose levels in America and England. A few studies, primarily randomized controlled trials, have been reported in China as well. METHOD Firstly, we designed two 'six-point formula' methods, which met the requirements of LCD and LFD, respectively. Fifty-six T2DM patients were recruited and randomly allocated to the LCD group (n = 28) and the LFD group (n = 28). The LCD group received education about LCD's six-point formula, while the LFD group received education about LFD's six-point formula. The follow-up time was three months. The indicators for glycemic control and other metabolic parameters were collected and compared between the two groups. RESULTS Forty-nine patients completed the study. The proportions of calories from three macronutrients the patients consumed met the requirements of LCD and LFD. Compared to the LFD group, there was a greater decrease in HbA1c level in the LCD group (-0.63% vs. -0.31%, p < 0.05). The dosages of insulin and fasting blood glucoses (FBG) in the third month were lower than those at baseline in both groups. Compared with baseline values, body mass index (BMI) and total cholesterol (TC) in the LCD group were significantly reduced in the third month (p < 0.05); however, there were no statistically significant differences in the LFD group. CONCLUSIONS LCD can improve blood glucose more than LFD in Chinese patients with T2DM. It can also regulate blood lipid, reduce BMI, and decrease insulin dose in patients with T2DM. In addition, the six-point formula is feasible, easily operable, and a practical educational diet for Chinese patients with T2DM.
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Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial.
Johansen, MY, MacDonald, CS, Hansen, KB, Karstoft, K, Christensen, R, Pedersen, M, Hansen, LS, Zacho, M, Wedell-Neergaard, AS, Nielsen, ST, et al
JAMA. 2017;318(7):637-646
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First-line treatment of Type 2 diabetes includes diet, physical activity, and weight loss prior to or in parallel with initiation of medication. The aim of this study was to examine whether an intensive lifestyle intervention results in equivalent blood sugar control compared with standard care. A secondary aim was to test whether an intensive lifestyle intervention leads to a reduction in glucose-lowering medication in participants with Type 2 diabetes. The study was a randomized, assessor-blind clinical study of 98 adults with Type 2 diabetes diagnosed for less than 10 years. The participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34). Results show that an intensive lifestyle intervention did not achieve comparable blood sugar control in comparison with standard care, however, the former led to a substantial and parallel reduction in glucose-lowering medication. The authors conclude that even though a lifestyle intervention compared to standard care did not result in the expected glycaemic control, it was still in a direction consistent with benefit.
Abstract
Importance: It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes. Objective: To test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes. Design, Setting, and Participants: Randomized, assessor-blinded, single-center study within Region Zealand and the Capital Region of Denmark (April 2015-August 2016). Ninety-eight adult participants with non-insulin-dependent type 2 diabetes who were diagnosed for less than 10 years were included. Participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34). Interventions: All participants received standard care with individual counseling and standardized, blinded, target-driven medical therapy. Additionally, the lifestyle intervention included 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months. Main Outcomes and Measures: Primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 12-month follow-up, and equivalence was prespecified by a CI margin of ±0.4% based on the intention-to-treat population. Superiority analysis was performed on the secondary outcome reductions in glucose-lowering medication. Results: Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA1c, 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA1c level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group (mean between-group difference in change of -0.26% [95% CI, -0.52% to -0.01%]), not meeting the criteria for equivalence (P = .15). Reduction in glucose-lowering medications occurred in 47 participants (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group (difference, 47.1 percentage points [95% CI, 28.6-65.3]). There were 32 adverse events (most commonly musculoskeletal pain or discomfort and mild hypoglycemia) in the lifestyle group and 5 in the standard care group. Conclusions and Relevance: Among adults with type 2 diabetes diagnosed for less than 10 years, a lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence, but was in a direction consistent with benefit. Further research is needed to assess superiority, as well as generalizability and durability of findings. Trial Registration: clinicaltrials.gov Identifier: NCT02417012.
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Impact of Consuming Extra-Virgin Olive Oil or Nuts within a Mediterranean Diet on DNA Methylation in Peripheral White Blood Cells within the PREDIMED-Navarra Randomized Controlled Trial: A Role for Dietary Lipids.
Arpón, A, Milagro, FI, Razquin, C, Corella, D, Estruch, R, Fitó, M, Marti, A, Martínez-González, MA, Ros, E, Salas-Salvadó, J, et al
Nutrients. 2017;10(1)
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Our genes are not fixed. They interact constantly with the environment through dietary and lifestyle factors, which affect whether genes are expressed or not. This is often referred to as epigenetic modulation. DNA methylation is an epigenetic mechanism that adds a methyl group to DNA, thereby modifying the function of the genes and affecting gene expression. Epigenetic alterations have been associated with conditions, such as obesity, type 2 diabetes, cardiovascular disease and immunological conditions. It is suggested that epigenetic marks are reversible and can be modulated by nutrient status and certain dietary components. The aim of the current study was to explore methylation changes in genes of peripheral white blood cells in a subset of participants from the PREDIMED-Navarra randomised controlled trial. 36 participants were allocated to three groups, all consuming a Mediterranean diet. In the first group, the diet was supplemented with extra virgin olive oil (EVOO), in the second group, with mixed nuts, and the third group, which served as the control group, were advised to consume a low-fat diet. Changes in DNA methylation were analysed from blood samples at baseline and at five-year follow-up. The authors observed methylation changes in several genes, related to metabolism, glucose and energy regulation, diabetes and inflammation, after the consumption of EVOO and nuts. They concluded that the beneficial effects of Mediterranean diets that include EVOO and nuts, may, at least in part, be mediated via epigenetic mechanisms. As these foods are high in monounsaturated and polyunsaturated fats, the quality of fat may be playing an important role in this mediation.
Abstract
DNA methylation could be reversible and mouldable by environmental factors, such as dietary exposures. The objective was to analyse whether an intervention with two Mediterranean diets, one rich in extra-virgin olive oil (MedDiet + EVOO) and the other one in nuts (MedDiet + nuts), was influencing the methylation status of peripheral white blood cells (PWBCs) genes. A subset of 36 representative individuals were selected within the PREvención con DIeta MEDiterránea (PREDIMED-Navarra) trial, with three intervention groups in high cardiovascular risk volunteers: MedDiet + EVOO, MedDiet + nuts, and a low-fat control group. Methylation was assessed at baseline and at five-year follow-up. Ingenuity pathway analysis showed routes with differentially methylated CpG sites (CpGs) related to intermediate metabolism, diabetes, inflammation, and signal transduction. Two CpGs were specifically selected: cg01081346-CPT1B/CHKB-CPT1B and cg17071192-GNAS/GNASAS, being associated with intermediate metabolism. Furthermore, cg01081346 was associated with PUFAs intake, showing a role for specific fatty acids on epigenetic modulation. Specific components of MedDiet, particularly nuts and EVOO, were able to induce methylation changes in several PWBCs genes. These changes may have potential benefits in health; especially those changes in genes related to intermediate metabolism, diabetes, inflammation and signal transduction, which may contribute to explain the role of MedDiet and fat quality on health outcomes.
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Effects of daily almond consumption on cardiometabolic risk and abdominal adiposity in healthy adults with elevated LDL-cholesterol: a randomized controlled trial.
Berryman, CE, West, SG, Fleming, JA, Bordi, PL, Kris-Etherton, PM
Journal of the American Heart Association. 2015;4(1):e000993
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Research has shown that almond consumption has a positive impact on cardiovascular risk factors and markers for inflammation. The aim of this randomised controlled trial was to compare a cholesterol lowering diet with almonds (1.5oz./day) with the same diet but substituting almonds with a calorie-matched food (i.e. a muffin) in a controlled-feeding setting. The study concluded that almonds reduce non high density lipoproteins, low-density lipoproteins and central adiposity in healthy individuals. The researchers suggest that it is likely to be almonds unique fatty acid profile and in particular, oleic acid that offers these cardiovascular protective effects. It recommended a daily intake of 1.5oz of almonds to replace high carbohydrate snacks.
Abstract
BACKGROUND Evidence consistently shows that almond consumption beneficially affects lipids and lipoproteins. Almonds, however, have not been evaluated in a controlled-feeding setting using a diet design with only a single, calorie-matched food substitution to assess their specific effects on cardiometabolic risk factors. METHODS AND RESULTS In a randomized, 2-period (6 week/period), crossover, controlled-feeding study of 48 individuals with elevated LDL-C (149±3 mg/dL), a cholesterol-lowering diet with almonds (1.5 oz. of almonds/day) was compared to an identical diet with an isocaloric muffin substitution (no almonds/day). Differences in the nutrient profiles of the control (58% CHO, 15% PRO, 26% total fat) and almond (51% CHO, 16% PRO, 32% total fat) diets were due to nutrients inherent to each snack; diets did not differ in saturated fat or cholesterol. The almond diet, compared with the control diet, decreased non-HDL-C (-6.9±2.4 mg/dL; P=0.01) and LDL-C (-5.3±1.9 mg/dL; P=0.01); furthermore, the control diet decreased HDL-C (-1.7±0.6 mg/dL; P<0.01). Almond consumption also reduced abdominal fat (-0.07±0.03 kg; P=0.02) and leg fat (-0.12±0.05 kg; P=0.02), despite no differences in total body weight. CONCLUSIONS Almonds reduced non-HDL-C, LDL-C, and central adiposity, important risk factors for cardiometabolic dysfunction, while maintaining HDL-C concentrations. Therefore, daily consumption of almonds (1.5 oz.), substituted for a high-carbohydrate snack, may be a simple dietary strategy to prevent the onset of cardiometabolic diseases in healthy individuals. CLINICAL TRIAL REGISTRATION URL www.clinicaltrials.gov; Unique Identifier: NCT01101230.