CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 609 enrolled
Drug / intervention
Low-Carbohydrate Diet +2 morebehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01826591
NCT01826591N/ACompleted

Do Insulin Secretion or Genotype Pattern Predict Low Fat vs Low Carb Weight Loss Success?

Stanford University·interventional·Posted Apr 8, 2013·Updated Feb 21, 2023

In Brief

A clinical study evaluating Low-Carbohydrate Diet, Low-Fat Diet, and 1 other intervention for Obesity and Insulin Resistance. Completed, enrolled 609 participants across 1 site.

Detailed Summary

Genomics research is advancing rapidly, and links between genes and obesity continue to be discovered and better defined. A growing number of single nucleotide polymorphisms (SNPs) in multiple genes have been shown to alter an individual's response to dietary macronutrient composition. Based on prior genetic studies evaluating the body's physiological responses to dietary carbohydrates or fats, the investigators identified multi-locus genotype patterns with SNPs from three genes (FABP2, PPARG, and ADRB2): a low carbohydrate-responsive genotype (LCG) and a low fat-responsive genotype (LFG). In a preliminary, retrospective study (using the A TO Z weight loss study data), the investigators observed a 3-fold difference in 12-month weight loss for initially overweight women who were determined to have been appropriately matched vs. mismatched to a low carbohydrate (Low Carb) or low fat (Low Fat) diet based on their multi-locus genotype pattern. The primary objective of this study is to confirm and expand on the preliminary results and determine if weight loss success can be increased if the dietary approach (Low Carb vs. Low Fat) is appropriately matched to an individual' s genetic predisposition (Low Carb Genotype vs. Low Fat Genotype) toward those diets.

Study Details

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 8, 2013
Enrollment StartJan 1, 2013
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.2 years ago

Interventions

Low-Carbohydrate Dietbehavioral

Counseling/instruction on how to follow a low-carbohydrate diet.

Low-Fat Dietbehavioral

Counseling/instruction on how to follow a low-fat diet.

Mobile Appbehavioral

Mobile app to increase vegetable consumption. Participants with iPhones will be re-randomized to receive a mobile app beginning at either months 4-5 or months 7-8. The first phase during months 4-7 will be used to compare the effect of a mobile app (intervention) vs. no mobile app (waiting-list control). The a priori hypothesis is that vegetable consumption will increase among those who receive the app in both diet groups.