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Safety and Tolerability of Whole Soybean Products: A Dose-Escalating Clinical Trial in Older Adults with Obesity.
Rebello, CJ, Boué, S, Levy, RJ, Puyau, R, Beyl, RA, Greenway, FL, Heiman, ML, Keller, JN, Reynolds, CF, Kirwan, JP
Nutrients. 2023;(8)
Abstract
Soybean products have nutrients, dietary fiber, and phytoalexins beneficial for cardiovascular and overall health. Despite their high consumption in Asian populations, their safety in Western diets is debated. We conducted a dose-escalating clinical trial of the safety and tolerability of soybean products in eight older adults (70-85 years) with obesity. Whole green soybean pods grown under controlled conditions were processed to flour (WGS) at the United States Department of Agriculture using common cooking techniques such as slicing and heat treatment. WGS incorporated into food products was consumed at 10 g, 20 g, and 30 g/day for one week at each dose. The gastrointestinal outcomes, clinical biomarkers, and adverse events were evaluated. We explored the stimulation of phytoalexin (glyceollin) production in live viable soybean seeds (LSS-G). We compared the compositions of WGS and LSS-G with commercial soybean flour and its fermented and enzymatically hydrolyzed forms. We found that although 30 g WSG was well-tolerated, and it made participants feel full. Our processing produced glyceollins (267 µg/g) in LSS-G. Processing soybean flour decreased the iron content, but reduced the oligosaccharides, which could attenuate flatulence. Providing soybean flour at <30 g/day may be prudent for overall health and to prevent the exclusion of other food groups and nutrients in older adults with obesity.
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Physiologic hormone administration improves HbA1C in Native Americans with type 2 diabetes: A retrospective study and review of insulin secretion and action.
Rebello, CJ, Morales, TS, Chuon, K, Dong, S, Lam, VT, Purner, D, Lewis, S, Lakey, J, Beyl, RA, Greenway, FL
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2023;(12):e13625
Abstract
Insulin is secreted in pulses from pancreatic beta-cells, and these oscillations maintain fasting plasma glucose levels within a narrow normal range. Within islets, beta-cells exhibit tight synchronization of regular oscillations. This control circuit is disrupted in type 2 diabetes, and irregularities in pulse frequency and amplitude occur. The prevalence of type 2 diabetes is three times higher in American Indian and Native Alaskans compared to Whites, and their genetic ancestry is associated with low beta-cell function. Obesity in this population compounds their vulnerability to adverse outcomes. The purpose of this article is to review insulin secretion and action and its interaction with race. We also present the results from a 6-month retrospective chart review of metabolic outcomes following intravenous physiologic hormone administration to 10 Native Americans. We found reductions in hemoglobin A1C (baseline: 9.03% ± 2.08%, 6 months: 7.03% ± 0.73%, p = 0.008), fasting glucose (baseline: 176.0 ± 42.85 mg/dL, 6 months: 137.11 ± 17.05 mg/dL, p = 0.02), homeostatic model assessment of insulin resistance (baseline: 10.39 ± 4.66, 6 months: 7.74 ± 4.22, p = 0.008), and triglycerides (baseline: 212.20 ± 101.44, 6 months: 165.50 ± 76.48 mg/dL, p = 0.02). Physiologic hormone administration may improve components of the metabolic syndrome. The therapy warrants investigation in randomized controlled trials.
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Effect of exercise training on insulin-stimulated glucose disposal: a systematic review and meta-analysis of randomized controlled trials.
Rebello, CJ, Zhang, D, Kirwan, JP, Lowe, AC, Emerson, CJ, Kracht, CL, Steib, LC, Greenway, FL, Johnson, WD, Brown, JC
International journal of obesity (2005). 2023;(5):348-357
Abstract
BACKGROUND AND OBJECTIVE The effect of exercise training on whole-body insulin sensitivity has not been systematically summarized. We aimed to summarize the data from randomized controlled trials evaluating the effect of exercise training on insulin action, in adults. SUBJECTS MEDLINE, EMBASE, and CENTRAL databases were searched until January 2021. Randomized controlled trials lasting ≥4 weeks, including adults, and evaluating the effect of exercise on insulin-stimulated glucose disposal measured using the hyperinsulinemic euglycemic clamp, were included. METHODS Three reviewers extracted summary data from published trials. The primary outcome was insulin-stimulated glucose disposal. Standardized weighted mean differences (SMD) in glucose disposal between intervention and control were compared. The PEDro scale was used to assess risk of bias. RESULTS We included 25 trials (36 interventions, N = 851). Exercise increased insulin-stimulated glucose disposal relative to control, SMD = 0.52 (95% confidence interval [CI]: 0.39, 0.65; p < 0.001; I2 = 47%) without significantly suppressing hepatic glucose production. In trials without isotopic tracers, exercise increased glucose disposal (SMD = 0.63; 95% CI: 0.48, 0.77; p < 0.001, I2 = 55%). In trials with isotopic tracers, exercise increased glucose disposal only when tracers were added to the exogenous glucose used for clamping (SMD = 0.34; 95% CI: 0.03, 0.66, p = 0.034. I2 = 0%). In a meta-regression model including aerobic exercise, weight change, and tracer technique, only percent weight change explained between trial heterogeneity (β = 0.069; 95% CI: 0.005, 0.013). The PEDro rating indicated relatively low risk of bias (5.8 ± 0.22). CONCLUSIONS Exercise training for at least four weeks significantly increases insulin-stimulated glucose disposal. Weight loss maximizes the effect and may be needed to improve hepatic insulin sensitivity. Differences in tracer methodology contribute to divergent outcomes and should be considered when assessing conclusions from research examining the effect of exercise on insulin action. REGISTRATION PROSPERO (CRD42019124381).
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Low-Energy Dense Potato- and Bean-Based Diets Reduce Body Weight and Insulin Resistance: A Randomized, Feeding, Equivalence Trial.
Rebello, CJ, Beyl, RA, Greenway, FL, Atteberry, KC, Hoddy, KK, Kirwan, JP
Journal of medicinal food. 2022;(12):1155-1163
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Abstract
We evaluated the effect of diets low in energy density (1 kcal/g) and high in either potatoes (Potato) or pulses (Bean) on blood glucose control in participants with insulin resistance. We hypothesized that the Potato and Bean diets would have equivalent effects. This was an 8-week randomized, parallel design, controlled feeding study comparing Potato and Bean diets (50-55% carbohydrate, 30-35% fat, 15-20% protein). Equivalence was prespecified as the mean change in the blood glucose concentration for Potato that was within ±20% of the Bean diet. Thirty-six participants (age: 18-60 years, body mass index: 25-40 kg/m2) with insulin resistance (homeostatic model assessment of insulin resistance [HOMA-IR] >2) were enrolled. Body weight was measured, and subjects underwent a mixed meal tolerance test at baseline and after 8 weeks. Intent-to-treat (ITT) and completer analyses were conducted. Equivalence between the two diets in the area under the curve for serum glucose was attained within ±10%, but the reduction from baseline was not statistically significant. For the Bean diet, insulin (area under the response curve: -2136.3 ± 955.5 mg/[dL∙min], P = .03) and HOMA-IR (-1.4 ± 0.6, P = .02) were lower compared with baseline. ITT and completer analyses were similar, except that HOMA-IR was also reduced by the Potato diet (-1.3 ± 0.6, P < .05). Compliance with the diets was 87-88%, and body weight was reduced in both diets (Potato: -5.6% ± 0.6%; Bean: -4.1% ± 0.6%, P < .001) with no significant difference between the two diets. Potato and Bean diets low in energy density were equally effective in reducing insulin resistance and promoting weight loss in individuals with impaired blood glucose control. Clinical Trial: The trial was registered with ClinicalTrials.gov Identifier: NCT04203238.
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Sympathomimetic increases resting energy expenditure following bariatric surgery: A randomized controlled clinical trial.
Rebello, CJ, Greenway, FL, Zhang, D, Johnson, WD, Patterson, E, Raum, W
Obesity (Silver Spring, Md.). 2022;(4):874-883
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Abstract
OBJECTIVE The aim of this study was to test the hypothesis that ephedrine + caffeine (EC) reduces the fall in resting energy expenditure (REE) following bariatric surgery. METHODS This 32-week, randomized, double-blinded, placebo-controlled trial included 142 patients who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) surgery. Participants were randomized to either EC or placebo for 27 weeks, beginning 5 weeks post surgery. The primary end points were change in REE (measured), percentage of predicted REE ([measured REE/Harris-Benedict equation-predicted REE] × 100), and body composition. Secondary outcomes included change in percentage of weight. Adverse events (AEs) were recorded. RESULTS The reduction in REE was smaller in the EC versus the placebo group, but it was not significant. Percentage of predicted REE was increased in the EC versus the placebo group (difference, mean [SE]: 5.82 [2.29], p = 0.013). Percentage of weight (difference: -3.83 [1.39], p = 0.007) was reduced in the EC versus the placebo group. Percentage of predicted REE was increased and body weight decreased in the EC-treated participants who underwent SG compared with those who underwent SG and were treated with placebo (difference in percentage of predicted REE = 8.06 [2.83], p = 0.006; difference in weight percentage = -4.37 [1.92], p = 0.025). Percentage of fat-free mass was increased in the SG participants treated with EC versus placebo (difference: 1.31 [0.63], p = 0.042). The most common AEs were anxiety, dizziness, insomnia, and tremors. Most AEs were not different from placebo by Week 32. CONCLUSIONS EC enhances weight loss and reduces the fall in REE following bariatric surgery. Adrenergic symptoms mostly resolve over time.
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A Snack Formulated with Ingredients to Slow Carbohydrate Digestion and Absorption Reduces the Glycemic Response in Humans: A Randomized Controlled Trial.
Rebello, CJ, Johnson, WD, Pan, Y, Larrivee, S, Zhang, D, Nisbet, M, Johnson, J, Chu, Y, Greenway, FL
Journal of medicinal food. 2020;23(1):21-28
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The rate, extent, and location of carbohydrate digestion and absorption are factors that influence metabolic outcomes. The aim of this study was to investigate the effect of a savoury snack (Test-snack) on the glycaemic response [changes in blood glucose after consuming a carbohydrate-containing food] in humans. The study is randomized, controlled crossover trial which enrolled twenty subjects, aged between 18 and 60 years. Each subject was randomly assigned to one of six unique orders for receiving the three interventions. Results show that the Test-snack formulated with ingredients and processes to slow carbohydrate digestion lowered the glycaemic response compared to the Control-snack. Furthermore, slowing of starch digestion influences subjective appetite ratings independent of the glycaemic response. Authors conclude that foods designed to slow starch digestion can help consumers meet their need to moderate the postprandial [after a meal] glycaemic response.
Abstract
This study compared the effect of a snack with ingredients to slow carbohydrate digestion (Test-snack) on postprandial blood glucose and insulin concentrations and subjective appetite ratings. We hypothesized that Test-snack would lower glucose and insulin responses and reduce appetite compared with a Control-snack. Overweight or obese subjects (n = 17) completed a randomized crossover study. Glucose, insulin, and appetite ratings were measured before consuming each snack or white bread (Bread) and over a period of 4 h. Subjects received Test-snack, Control-snack, or Bread in random order at least a week apart. The a priori primary outcome was the glucose response, and the secondary outcomes were appetite ratings and insulin responses. Mixed effects statistical models were used to perform analysis of variance in terms of the area under curve (AUC) and at specific time points. The 2-h AUC for glucose was significantly lower with Test-snack compared to Control-snack and Bread (AUC and 95% confidence intervals: Test = 2186.43 [1783.36-2589.51]; Control = 3293.75 [2893.97-3693.54]; Bread = 2800.28 [2405.79-3194.77] mg/dL · min). Four-hour AUC for glucose, and insulin, followed a similar pattern except that Test-snack did not differ from Bread. The glucose concentrations peaked at 45 min under all three conditions, but Test-snack elicited a lower response than Control-snack and Bread (P < .01). Test increased fullness and satisfaction and reduced hunger and prospective intake compared to Bread (P < .02), but was not significantly different from Control-snack. Ingredients that slow carbohydrate digestion in a snack reduce the postprandial glucose and insulin responses compared to a product without these ingredients.
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Naringenin Increases Insulin Sensitivity and Metabolic Rate: A Case Study.
Murugesan, N, Woodard, K, Ramaraju, R, Greenway, FL, Coulter, AA, Rebello, CJ
Journal of medicinal food. 2020;(3):343-348
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Our studies in primary human adipocytes show that naringenin, a citrus flavonoid, increases oxygen consumption rate and gene expression of uncoupling protein 1 (UCP1), glucose transporter type 4, and carnitine palmitoyltransferase 1β (CPT1β). We investigated the safety of naringenin, its effects on metabolic rate, and blood glucose and insulin responses in a single female subject with diabetes. The subject ingested 150 mg naringenin from an extract of whole oranges standardized to 28% naringenin three times/day for 8 weeks, and maintained her usual food intake. Body weight, resting metabolic rate, respiratory quotient, and blood chemistry panel including glucose, insulin, and safety markers were measured at baseline and after 8 weeks. Adverse events were evaluated every 2 weeks. We also examined the involvement of peroxisome proliferator-activated receptor α (PPARα), peroxisome proliferator-activated receptor γ (PPARγ), protein kinase A (PKA), and protein kinase G (PKG) in the response of human adipocytes to naringenin treatment. Compared to baseline, the body weight decreased by 2.3 kg. The metabolic rate peaked at 3.5% above baseline at 1 h, but there was no change in the respiratory quotient. Compared to baseline, insulin decreased by 18%, but the change in glucose was not clinically significant. Other blood safety markers were within their reference ranges, and there were no adverse events. UCP1 and CPT1β mRNA expression was reduced by inhibitors of PPARα and PPARγ, but there was no effect of PKA or PKG inhibition. We conclude that naringenin supplementation is safe in humans, reduces body weight and insulin resistance, and increases metabolic rate by PPARα and PPARγ activation. The effects of naringenin on energy expenditure and insulin sensitivity warrant investigation in a randomized controlled clinical trial.
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Behavioral Determinants of Objectively Assessed Diet Quality in Obese Pregnancy.
Most, J, Rebello, CJ, Altazan, AD, Martin, CK, Amant, MS, Redman, LM
Nutrients. 2019;(7)
Abstract
Interventions to promote healthy pregnancy in women with obesity by improving diet quality have been widely unsuccessful. We hypothesized that diet quality is determined by eating behaviors, but evidence in women with obesity is lacking. We evaluated diet quality and eating behavior in 56 women with obesity (mean ± SEM, 36.7 ± 0.7 kg/m2, 46% White, 50% nulliparous) early in pregnancy (14.9 ± 0.1 weeks). Diet quality was objectively assessed with food photography over six days and defined by Healthy Eating Index. Eating behaviors were assessed by validated questionnaires. Women reported consuming diets high in fat (38 ± 1% of energy) and the HEI was considered "poor" on average (46.7 ± 1.3), and for 71% of women. Diet quality was independently associated with education level (p = 0.01), food cravings (p < 0.01), and awareness towards eating (p = 0.01). Cravings for sweets and fast foods were positively correlated with respective intakes of these foods (p < 0.01 and p = 0.04, respectively), whereas cravings for fruits and vegetables did not relate to diet intake. We provide evidence of the determinants of poor diet quality in pregnant women with obesity. Based on this observational study, strategies to improve diet quality and pregnancy outcomes are to satisfy cravings for healthy snacks and foods, and to promote awareness towards eating behaviors.
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Effect of Lorcaserin Alone and in Combination with Phentermine on Food Cravings After 12-Week Treatment: A Randomized Substudy.
Rebello, CJ, Nikonova, EV, Zhou, S, Aronne, LJ, Fujioka, K, Garvey, WT, Smith, SR, Coulter, AA, Greenway, FL
Obesity (Silver Spring, Md.). 2018;(2):332-339
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Abstract
OBJECTIVE This study evaluated the effect of lorcaserin 10 mg twice daily (LOR BID), or with phentermine 15 mg once daily (LOR BID + PHEN QD) and 15 mg twice daily (LOR BID + PHEN BID), in conjunction with energy restriction on food cravings. METHODS Two hundred and thirty-five patients without diabetes but with obesity or overweight and ≥ 1 comorbidity received LOR BID, LOR BID + PHEN QD, or LOR BID + PHEN BID for 12 weeks in a randomized double-blind study. The Food Craving Inventory (FCI) and the Control of Eating Questionnaire (COEQ) were administered over 12 weeks. RESULTS The FCI total score and the subscale scores reduced from baseline in all groups. The least squares means (95% confidence intervals) for the total scores were -0.65 (-0.75 to -0.55), -0.75 (-0.84 to -0.65), and -0.84 (-0.95 to -0.74) in the LOR BID, LOR BID + PHEN QD, and LOR BID + PHEN BID groups, respectively. Cravings assessed by COEQ reduced from baseline in all groups. In general, the combination treatments were more effective than lorcaserin alone. At week 12, except for fruit juice and dairy products, general and specific cravings reduced in LOR BID + PHEN BID compared with LOR BID (P < 0.05). CONCLUSIONS Lorcaserin in combination with phentermine improves control of food cravings during short-term energy restriction.
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Instant Oatmeal Increases Satiety and Reduces Energy Intake Compared to a Ready-to-Eat Oat-Based Breakfast Cereal: A Randomized Crossover Trial.
Rebello, CJ, Johnson, WD, Martin, CK, Han, H, Chu, YF, Bordenave, N, van Klinken, BJ, O'Shea, M, Greenway, FL
Journal of the American College of Nutrition. 2016;(1):41-9
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Abstract
BACKGROUND Foods that enhance satiety can help consumers to resist environmental cues to eat and help adherence to calorie restriction. The objective of this study was to compare the effect of 2 oat-based breakfast cereals on appetite, satiety, and food intake. METHODS Forty-eight healthy individuals, 18 years of age or older, were enrolled in a randomized, crossover trial. Subjects consumed isocaloric servings of either oatmeal or an oat-based ready-to-eat breakfast cereal (RTEC) in random order at least a week apart. Visual analogue scales measuring appetite and satiety were completed before breakfast and throughout the morning. Lunch was served 4 hours after breakfast. The physicochemical properties of oat soluble fiber (β-glucan) were determined. Appetite and satiety responses were analyzed by area under the curve. Food intake and β-glucan properties were analyzed using t tests. RESULTS Oatmeal increased fullness (p = 0.001) and reduced hunger (p = 0.005), desire to eat (p = 0.001), and prospective intake (p = 0.006) more than the RTEC. Energy intake at lunch was lower after eating oatmeal compared to the RTEC (p = 0.012). Oatmeal had higher viscosity (p = 0.03), β-glucan content, molecular weight (p < 0.001), and radius of gyration (p < 0.001) than the RTEC. CONCLUSIONS Oatmeal suppresses appetite, increases satiety, and reduces energy intake compared to the RTEC. The physicochemical properties of β-glucan and sufficient hydration of oats are important factors affecting satiety and subsequent energy intake.