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| Name | Class |
|---|---|
| Yale University | OTHER |
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The goal of this 16-week clinical trial is to assess the health benefits of a low-fat vegan diet on insulin sensitivity and glycemic control in type 2 diabetes. Participants will receive at no cost, study-related weekly nutrition education classes and one-on-one consultation with a registered dietitian.
This study tests the hypothesis that fat content in muscle and liver cells will be reduced and changes in insulin sensitivity will be observed in response to a low-fat vegan diet intervention.
The study will be carried out online (via Zoom or a similar platform). Participants will be asked to attend weekly online classes on nutrition and health.
The study will also require in-person meetings. Participants will travel to the Physicians Committee of Responsible Medicine, Washington, DC, at the beginning of the study (week 0) and the end of the study (week 16) to complete bloodwork (comprehensive metabolic panel, lipid panel, and HbA1c) and several medical tests (standard meal test, indirect calorimetry, dual-energy x-ray absorptiometry [DEXA Scan, an imaging test that measures changes in bone mineral density/bone strength], and Advanced Glycation End-products measurement). They will also need to travel to the Magnetic Research Center at Yale University School of Medicine, New Haven, CT at the beginning of the study (week 0) and the end of the study (week 16) to have a Magnetic Resonance (MR) spectroscopy to quantify liver and muscle fat content.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group: low-fat vegan diet | Experimental | This arm of participants will be asked to attend weekly online classes in nutrition and health and to follow a low-fat, vegan diet for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-fat vegan diet | Behavioral | The intervention diet consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Participants will also be guided to favor foods with a low glycemic index. Animal products and added oils will be excluded. The diet is designed to derive approximately 10% of energy from fat, approximately 10-15% of energy from protein, and the remainder from mostly complex carbohydrates. The diet will also provide approximately 40 g of fiber per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Intramyocellular and Hepatocellular Lipid Content | MR spectroscopy will be used to quantify liver and muscle fat content. This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in intramyocellular and hepatocellular lipid content. | 16-weeks |
| Insulin sensitivity and β-cell function | These will be assessed during a standard meal test (Boost Plus, Nestle, Vevey, Switzerland; 720 kcal, 34% of energy from fat, 16% protein, 50% carbohydrate). Plasma concentrations of glucose, immunoreactive insulin, and C-peptide will be measured at 0, 30, 60, 120, and 180 min. Insulin secretory rates will be calculated from plasma C-peptide levels by deconvolution49 and expressed per square meter of estimated body surface area. This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in insulin sensitivity and β-cell function. | 16-weeks |
| Resting energy expenditure and postprandial metabolism | This will be measured by indirect calorimetry. Participants will be asked to report to the laboratory within 60 minutes of waking and after a 12-hour fast. Resting energy expenditure will be measured for 20 minutes through indirect calorimetry, utilizing a ventilated hood system. Postprandial metabolism will be measured for 20 minutes in the last hour of the meal test, i.e. 2 hours after the standard breakfast. This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in resting energy expenditure and postprandial metabolism. | 16-weeks |
| Body Composition | This will be measured by dual-energy x-ray absorptiometry (Lunar iDXA). The iDXA can measure body composition with low X-ray exposure and short scanning time. This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in body composition. | 16-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Diet Quality | In addition, this study will assess the association between attending a series of plant-based nutrition classes on pre-post changes in diet quality. Diet quality will be determined using the alternate eating index. | 16-weeks |
| Food Acceptability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hana Kahleova, MD, PhD | Physicians Committee for Responsible Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Committee for Responsible Medicine | Washington D.C. | District of Columbia | 20016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37669055 | Background | Kahleova H, Sutton M, Maracine C, Nichols D, Monsivais P, Holubkov R, Barnard ND. Vegan Diet and Food Costs Among Adults With Overweight: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2332106. doi: 10.1001/jamanetworkopen.2023.32106. | |
| 33252690 | Background | Kahleova H, Petersen KF, Shulman GI, Alwarith J, Rembert E, Tura A, Hill M, Holubkov R, Barnard ND. Effect of a Low-Fat Vegan Diet on Body Weight, Insulin Sensitivity, Postprandial Metabolism, and Intramyocellular and Hepatocellular Lipid Levels in Overweight Adults: A Randomized Clinical Trial. JAMA Netw Open. 2020 Nov 2;3(11):e2025454. doi: 10.1001/jamanetworkopen.2020.25454. |
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All individuals will be on a low-fat vegan diet for the duration of the study.
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|
| Advanced Glycation End-products (AGE) | This will be measured using the Advanced Glycation End-products (AGE) Reader made by Diagnoptics. AGE Reader measures the skin fluorescence to quantify the tissue accumulation of AGE's. This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in advanced glycation end-products (AGE). | 16-weeks |
| Continuous glucose monitoring | To provide glucose readings throughout the day, participants will be provided with a continuous glucose monitoring (CGM) system that measures glucose concentrations between 40 and 400 mg/dL every 5 minutes for up to 7 days by sampling interstitial fluid. The participants who are at risk of hypoglycemia will be encouraged to use CGM throughout the whole study. | 16-weeks |
| Body Weight | This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in body weight. | 16-weeks |
| Plasma Lipid Concentrations | This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in plasma lipid concentrations. | 16-weeks |
| HbA1c | This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in glycemic control in individuals with type 2 diabetes as assessed by hemoglobin A1c (HbA1c) and use of medication. | 16-weeks |
This study will assess the association between attending a series of plant-based nutrition classes on pre-post changes in food acceptability. The Food Acceptability Questionnaire (FAQ) will measure attitudes about the intervention diet, the effort required to follow it, and the likelihood of continued adherence to it in the future. |
| 16-weeks |
| Food Cost | This study will assess the association between attending a series of plant-based nutrition classes on pre-post changes in food cost. The food cost will be determined using the 3-day diet records and the United States Department of Agriculture (USDA) Thrifty Plan 2021. | 16-weeks |
| 25091356 | Background | Yatsuya H, Nihashi T, Li Y, Hotta Y, Matsushita K, Muramatsu T, Otsuka R, Matsunaga M, Yamashita K, Wang C, Uemura M, Harada A, Fukatsu H, Toyoshima H, Aoyama A, Tamakoshi K. Independent association of liver fat accumulation with insulin resistance. Obes Res Clin Pract. 2014 Jul-Aug;8(4):e350-5. doi: 10.1016/j.orcp.2013.08.002. Epub 2013 Sep 5. |
| 16873779 | Background | Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606. |
| 12086926 | Background | Itani SI, Ruderman NB, Schmieder F, Boden G. Lipid-induced insulin resistance in human muscle is associated with changes in diacylglycerol, protein kinase C, and IkappaB-alpha. Diabetes. 2002 Jul;51(7):2005-11. doi: 10.2337/diabetes.51.7.2005. |
| 11679437 | Background | Bachmann OP, Dahl DB, Brechtel K, Machann J, Haap M, Maier T, Loviscach M, Stumvoll M, Claussen CD, Schick F, Haring HU, Jacob S. Effects of intravenous and dietary lipid challenge on intramyocellular lipid content and the relation with insulin sensitivity in humans. Diabetes. 2001 Nov;50(11):2579-84. doi: 10.2337/diabetes.50.11.2579. |
| 10778870 | Background | Goodpaster BH, Theriault R, Watkins SC, Kelley DE. Intramuscular lipid content is increased in obesity and decreased by weight loss. Metabolism. 2000 Apr;49(4):467-72. doi: 10.1016/s0026-0495(00)80010-4. |
| 10027589 | Background | Krssak M, Falk Petersen K, Dresner A, DiPietro L, Vogel SM, Rothman DL, Roden M, Shulman GI. Intramyocellular lipid concentrations are correlated with insulin sensitivity in humans: a 1H NMR spectroscopy study. Diabetologia. 1999 Jan;42(1):113-6. doi: 10.1007/s001250051123. |
| 10426379 | Background | Perseghin G, Scifo P, De Cobelli F, Pagliato E, Battezzati A, Arcelloni C, Vanzulli A, Testolin G, Pozza G, Del Maschio A, Luzi L. Intramyocellular triglyceride content is a determinant of in vivo insulin resistance in humans: a 1H-13C nuclear magnetic resonance spectroscopy assessment in offspring of type 2 diabetic parents. Diabetes. 1999 Aug;48(8):1600-6. doi: 10.2337/diabetes.48.8.1600. |
| 10731493 | Background | Goodpaster BH, Thaete FL, Kelley DE. Thigh adipose tissue distribution is associated with insulin resistance in obesity and in type 2 diabetes mellitus. Am J Clin Nutr. 2000 Apr;71(4):885-92. doi: 10.1093/ajcn/71.4.885. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| D000095500 | Diet, Plant-Based |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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