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CompletedNCT00858312

Dairy Foods and Weight Loss

Role of Dairy Foods to Enhance Central Fat and Weight Loss With Moderate Energy Restriction in Overweight and Obesity Individuals

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
78 (actual)
Sponsor
USDA, Western Human Nutrition Research Center · Federal
Sex
All
Age
20 Years – 50 Years
Healthy volunteers
Accepted

Summary

Obesity is a national epidemic with multiple causes and complex solutions. Research in both animals and humans has suggested that the inclusion of dairy foods into a moderate calorie restricted diet can increase weight loss and fat loss. Our proposed project extends these prior findings by determining, for the first time, how inclusion of dairy in a calorie-restricted diet changes the amount of visceral adiposity in overweight and obese subjects. The investigators also propose unique studies to evaluate the potential mechanism(s) by which dairy promotes weight and fat loss during dieting, through an examination of adipocyte size, gene expression, and inflammatory markers. The hypotheses under investigation are (1) that inclusion of dairy foods in a modest energy restricted diet will significantly increase body fat loss compared to a control diet; (2) that dairy products in a modest energy restricted diet will result in greater fat loss from intra-abdominal adipose tissue compared to the control, 3) components of dairy products up- or down-regulate the secretion of metabolically-relevant hormones during the postprandial and inter-meal periods, 4) dairy products will promote satiety and/or satiation, 5) dairy foods reduce adipocyte differentiation and/or enhance adipocyte apoptosis, leading to concomitant white adipose tissue (WAT) expression changes for genes playing a role in these processes, 6) dairy foods will reduce adipocyte lipid storage and enhance pathways associated with thermogenesis and mitochondrial function in WAT, as reflected in gene expression changes and reduced adipocyte size, and 7) dairy foods included in a modest energy restricted diet will decrease inflammation in WAT and other tissues, thus decreasing circulating cytokines, increasing zinc status, decreasing expression of inflammatory markers in WAT, and reducing WAT macrophage infiltration.

Detailed description

84 overweight and overweight and obese adult males and females will be recruited from the faculty, staff, and student populations at University of California-Davis as well as the greater Davis and Sacramento communities. Each intervention arm will require 42 adults; 35 for statistical power on weight loss + 14 more for attrition during the weight loss intervention. Statistical power for fat loss requires only 20 subjects/treatment arm. Subjects will be enrolled in 7 cohorts of 12 each and will be randomly assigned to either control or dairy diets. Subjects will meet the following additional inclusion and exclusion criteria:

Conditions

Interventions

TypeNameDescription
OTHERhigh dairy diet12 week energy restriction with 3-4 servings of dairy foods/day.
OTHERLow Dairyless than 1 serving of dairy foods per day.

Timeline

Start date
2006-10-01
Primary completion
2009-08-01
Completion
2009-08-01
First posted
2009-03-09
Last updated
2025-03-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00858312. Inclusion in this directory is not an endorsement.

Dairy Foods and Weight Loss (NCT00858312) · Clinical Trials Directory