Popular Diets Study

NCT ID: NCT00315354

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2013-04-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Obesity Insulin Resistance

Keywords

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obesity nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Low glycemic index diet

Group Type EXPERIMENTAL

Low glycemic index diet

Intervention Type OTHER

Feeding protocol, all foods prepared in a metabolic kitchen

2

Low fat diet

Group Type ACTIVE_COMPARATOR

Low fat diet

Intervention Type OTHER

Feeding protocol, all foods prepared in a metabolic kitchen

3

Very low carbohydrate diet

Group Type ACTIVE_COMPARATOR

Very low carbohydrate diet

Intervention Type OTHER

Feeding protocol, all foods prepared in a metabolic kitchen

Interventions

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Low glycemic index diet

Feeding protocol, all foods prepared in a metabolic kitchen

Intervention Type OTHER

Low fat diet

Feeding protocol, all foods prepared in a metabolic kitchen

Intervention Type OTHER

Very low carbohydrate diet

Feeding protocol, all foods prepared in a metabolic kitchen

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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David S. Ludwig, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David S Ludwig, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Cara B Ebbeling, PhD

Role: STUDY_DIRECTOR

Boston Children's Hospital

Locations

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Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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. Epub 2013 Mar 6.

Reference Type RESULT
PMID: 23483989 (View on PubMed)

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.

Reference Type RESULT
PMID: 22735432 (View on PubMed)

Hron BM, Ebbeling CB, Feldman HA, Ludwig DS. Hepatic, adipocyte, enteric and pancreatic hormones: response to dietary macronutrient composition and relationship with metabolism. Nutr Metab (Lond). 2017 Jul 5;14:44. doi: 10.1186/s12986-017-0198-y. eCollection 2017.

Reference Type DERIVED
PMID: 28694840 (View on PubMed)

Esko T, Hirschhorn JN, Feldman HA, Hsu YH, Deik AA, Clish CB, Ebbeling CB, Ludwig DS. Metabolomic profiles as reliable biomarkers of dietary composition. Am J Clin Nutr. 2017 Mar;105(3):547-554. doi: 10.3945/ajcn.116.144428. Epub 2017 Jan 11.

Reference Type DERIVED
PMID: 28077380 (View on PubMed)

Other Identifiers

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R01DK072428

Identifier Type: NIH

Identifier Source: secondary_id

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1R01DK072428

Identifier Type: NIH

Identifier Source: org_study_id

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