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Popular Diets Study

Primary Purpose

Obesity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low glycemic index diet
Low fat diet
Very low carbohydrate diet
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring obesity, nutrition

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Low glycemic index diet

Low fat diet

Very low carbohydrate diet

Outcomes

Primary Outcome Measures

resting energy expenditure using indirect calorimetry in the fasting state
insulin resistance assessed by frequently-sampled oral glucose tolerance test
thyroid function tests

Secondary Outcome Measures

total energy expenditure using doubly labeled water methodology
thermic effect of food using indirect calorimetry
physical activity using accelerometry
serum lipids
plasminogen activator inhibitor-1
C-reactive protein
blood pressure
hunger/appetite
insulin 30 minutes after oral glucose (as an effect modifier)
Core temperature
secreted frizzle-related protein-4
heme-oxygenase
Irisin
fibroblast growth factor-21
chemerin
trimethylamine N-oxide
alanine aminotransferase
Uric acid
insulin
ghrelin
gastric inhibitory peptide
GLP1
PYY
Amylin
Leptin
Metabolomic analysis
Evaluate the effect of diet on metabolomic profile in plasma, with the aim of assessing dietary adherence and exploring diet-disease mechanisms

Full Information

First Posted
April 14, 2006
Last Updated
November 22, 2016
Sponsor
Boston Children's Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00315354
Brief Title
Popular Diets Study
Official Title
Popular Diets, Metabolism, and CVD Risk
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Brigham and Women's Hospital

4. Oversight

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
Keywords
obesity, nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Low glycemic index diet
Arm Title
2
Arm Type
Active Comparator
Arm Description
Low fat diet
Arm Title
3
Arm Type
Active Comparator
Arm Description
Very low carbohydrate diet
Intervention Type
Other
Intervention Name(s)
Low glycemic index diet
Intervention Description
Feeding protocol, all foods prepared in a metabolic kitchen
Intervention Type
Other
Intervention Name(s)
Low fat diet
Intervention Description
Feeding protocol, all foods prepared in a metabolic kitchen
Intervention Type
Other
Intervention Name(s)
Very low carbohydrate diet
Intervention Description
Feeding protocol, all foods prepared in a metabolic kitchen
Primary Outcome Measure Information:
Title
resting energy expenditure using indirect calorimetry in the fasting state
Time Frame
end of each dietary period
Title
insulin resistance assessed by frequently-sampled oral glucose tolerance test
Time Frame
end of each dietary period
Title
thyroid function tests
Time Frame
end of each dietary period
Secondary Outcome Measure Information:
Title
total energy expenditure using doubly labeled water methodology
Time Frame
end of each dietary period
Title
thermic effect of food using indirect calorimetry
Time Frame
end of each dietary period
Title
physical activity using accelerometry
Time Frame
end of each dietary period
Title
serum lipids
Time Frame
end of each dietary period
Title
plasminogen activator inhibitor-1
Time Frame
end of each dietary period
Title
C-reactive protein
Time Frame
end of each dietary period
Title
blood pressure
Time Frame
end of each dietary period
Title
hunger/appetite
Time Frame
end of each dietary period
Title
insulin 30 minutes after oral glucose (as an effect modifier)
Time Frame
baseline
Title
Core temperature
Time Frame
End of each dietary period
Title
secreted frizzle-related protein-4
Time Frame
end of each dietary period
Title
heme-oxygenase
Time Frame
end of each dietary period
Title
Irisin
Time Frame
end of each dietary period
Title
fibroblast growth factor-21
Time Frame
end of each dietary period
Title
chemerin
Time Frame
end of each dietary period
Title
trimethylamine N-oxide
Time Frame
fasting and postprandial, end of each dietary period
Title
alanine aminotransferase
Time Frame
end of each dietary period
Title
Uric acid
Time Frame
end of each dietary period
Title
insulin
Time Frame
fasting and postprandial, end of each dietary period
Title
ghrelin
Time Frame
fasting and postprandial, end of each dietary period
Title
gastric inhibitory peptide
Time Frame
fasting and postprandial, end of each dietary period
Title
GLP1
Time Frame
fasting and postprandial, end of each dietary period
Title
PYY
Time Frame
fasting and postprandial, end of each dietary period
Title
Amylin
Time Frame
fasting and postprandial, end of each dietary period
Title
Leptin
Time Frame
end of each dietary period
Title
Metabolomic analysis
Description
Evaluate the effect of diet on metabolomic profile in plasma, with the aim of assessing dietary adherence and exploring diet-disease mechanisms
Time Frame
end of each dietary period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Ludwig, MD, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cara B Ebbeling, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23483989
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. Epub 2013 Mar 6.
Results Reference
result
PubMed Identifier
22735432
Citation
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.
Results Reference
result
PubMed Identifier
28694840
Citation
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.
Results Reference
derived
PubMed Identifier
28077380
Citation
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. Erratum In: Am J Clin Nutr. 2022 Feb 9;115(2):601.
Results Reference
derived

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Popular Diets Study

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