Popular Diets Study

Obesity Clinical Trial

Official title:

Popular Diets, Metabolism, and CVD Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315354
• Other study ID #: 1R01DK072428
• Secondary ID: R01DK072428
• Status: Completed
• Phase: N/A
• First received: April 14, 2006
• Last updated: November 22, 2016
• Start date: April 2006
• Est. completion date: April 2013

Study information

• Verified date: November 2016
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effects of three dominant dietary patterns - conventional low-fat, low-glycemic index (GI) and very-low-carbohydrate - on energy metabolism and heart disease risk factors following weight loss in obese young adults in a feeding study

Description:

For most of the last half century, reduction in fat intake has been the primary nutritional approach for the prevention and treatment of obesity and cardiovascular disease (CVD). Over the last few years, very low carbohydrate (Atkins-type) diets have achieved great popularity, with publication of several studies suggesting greater weight loss and improvements in CVD risk factors over 3 to 6 months. Recently, a third dietary approach focused on glycemic index (GI) has generated interest. However, few studies have compared the effects of these diets on body weight regulation and risk for CVD. The primary hypotheses of this study are that any diet that lowers the postprandial rise in blood glucose (very-low-carbohydrate or low-GI) will have beneficial effects on the physiological adaptations to weight loss and on some CVD risk factors. However, other CVD risk factors will be adversely affected by a very-low-carbohydrate vs. a low-GI diet. Preliminary data provide strong support for these hypotheses, by showing that resting energy expenditure declines less and CVD risk factors improve more with weight loss on a low-glycemic load diet compared to a conventional low-fat diet. This application proposes a cross-over feeding design to study the effects of three diets following 12.5% weight loss in obese young adult subjects (n = 24, age 18 to 40 years). The diets are: 1) conventional low-fat, with 60% carb, 20% fat, 20% protein; 2) low-GI with 40% carb, 40% fat, 20% protein; and 3) very-low-carbohydrate with 10% carb, 60% fat, 30% protein. The primary outcome is resting energy expenditure (indirect calorimetry). Secondary outcomes include total energy expenditure (doubly labeled water), thermic effect of food (indirect calorimetry), physical activity (accelerometry), insulin resistance and B-cell function (frequently-sampled OGTT), blood lipids, blood pressure and measures of systemic inflammation and coagulopathy. This study should have major public health implications to the millions of Americans currently following diets to decrease body weight and risk for heart disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2013
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• BMI = 27 kg/m2

• Willing and able to come to the GCRC 5 days per week to consume a supervised meal and pick-up food for all other meals

• Available for scheduled hospital admissions

• Willing to abstain from alcohol consumption for the duration of the study

• If female, regular menstrual cycles (defined as 26 to 30 days between cycles; no more than one day variation in the duration of menstrual flow)

Exclusion Criteria:

• Weight > 350 lbs

• Change in body weight (± 10%) over preceding year

• Taking any medications or dietary supplements that might affect body weight, appetite, or energy expenditure

• Smoking (1 cigarette in the last week)

• High levels of physical activity

• Currently following a special diet

• Abnormal laboratory screening tests

• Type 2 diabetes mellitus

• Allergies or aversions to foods on the study menu

• Previous diagnosis of an eating disorder or any other mental health disorder

• If female, pregnant in the past 12 months or planning to become pregnant during the study period

• If female, lactating in the preceding 12 months

• If taking birth control medication, change in medication in previous 3 months or plans to change medication during the study period

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Other:
• Low glycemic index diet
Feeding protocol, all foods prepared in a metabolic kitchen
• Low fat diet
Feeding protocol, all foods prepared in a metabolic kitchen
• Very low carbohydrate diet
Feeding protocol, all foods prepared in a metabolic kitchen

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Children’s Hospital	Brigham and Women's Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Ebbeling CB, Swain JF, Feldman HA, Wong WW, Hachey DL, Garcia-Lago E, Ludwig DS. Effects of dietary composition on energy expenditure during weight-loss maintenance. JAMA. 2012 Jun 27;307(24):2627-34. doi: 10.1001/jama.2012.6607. — View Citation

Walsh CO, Ebbeling CB, Swain JF, Markowitz RL, Feldman HA, Ludwig DS. Effects of diet composition on postprandial energy availability during weight loss maintenance. PLoS One. 2013;8(3):e58172. doi: 10.1371/journal.pone.0058172. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resting energy expenditure using indirect calorimetry in the fasting state		end of each dietary period	No
Primary	insulin resistance assessed by frequently-sampled oral glucose tolerance test		end of each dietary period	No
Primary	thyroid function tests		end of each dietary period	No
Secondary	total energy expenditure using doubly labeled water methodology		end of each dietary period	No
Secondary	thermic effect of food using indirect calorimetry		end of each dietary period	No
Secondary	physical activity using accelerometry		end of each dietary period	No
Secondary	serum lipids		end of each dietary period	No
Secondary	plasminogen activator inhibitor-1		end of each dietary period	No
Secondary	C-reactive protein		end of each dietary period	No
Secondary	blood pressure		end of each dietary period	No
Secondary	hunger/appetite		end of each dietary period	No
Secondary	insulin 30 minutes after oral glucose (as an effect modifier)		baseline	No
Secondary	Core temperature		End of each dietary period	No
Secondary	secreted frizzle-related protein-4		end of each dietary period	No
Secondary	heme-oxygenase		end of each dietary period	No
Secondary	Irisin		end of each dietary period	No
Secondary	fibroblast growth factor-21		end of each dietary period	No
Secondary	chemerin		end of each dietary period	No
Secondary	trimethylamine N-oxide		fasting and postprandial, end of each dietary period	No
Secondary	alanine aminotransferase		end of each dietary period	No
Secondary	Uric acid		end of each dietary period	No
Secondary	insulin		fasting and postprandial, end of each dietary period	No
Secondary	ghrelin		fasting and postprandial, end of each dietary period	No
Secondary	gastric inhibitory peptide		fasting and postprandial, end of each dietary period	No
Secondary	GLP1		fasting and postprandial, end of each dietary period	No
Secondary	PYY		fasting and postprandial, end of each dietary period	No
Secondary	Amylin		fasting and postprandial, end of each dietary period	No
Secondary	Leptin		end of each dietary period	No
Secondary	Metabolomic analysis	Evaluate the effect of diet on metabolomic profile in plasma, with the aim of assessing dietary adherence and exploring diet-disease mechanisms	end of each dietary period	No