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Sponsors and Collaborators: |
USDA, Western Human Nutrition Research Center Iowa State University |
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Information provided by: | USDA, Western Human Nutrition Research Center |
ClinicalTrials.gov Identifier: | NCT00858312 |
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.
Condition | Intervention | Phase |
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Overweight and Obesity |
Other: high dairy diet Other: Low Dairy |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Role of Dairy Foods to Enhance Central Fat and Weight Loss With Moderate Energy Restriction in Overweight and Obesity Individuals |
Estimated Enrollment: | 72 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Diet with 3-4 servings of dairy-rich foods/day
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Other: high dairy diet
12 week energy restriction with 3-4 servings of dairy foods/day.
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2: Placebo Comparator
Low Dairy < 1 serving of dairy food/day
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Other: Low Dairy
less than 1 serving of dairy foods per day.
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84 overweight and overweight and obese adult males and females will be recruited from the faculty, staff, and student populations at UC-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:
Ages Eligible for Study: | 20 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Pregnancy testing will also be done at the end of the study prior to DXA and abdominal CT scans
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Exclusion Criteria:
BMI<28or>37. BMI greater than 37 indicates another level of obesity and the potential for numerous obesity related endocrine changes and substrate utilization abnormalities.
Contact: Marta D Van Loan, Ph.D. | 530-752-4160 | marta.vanloan@ars.usda.gov |
United States, California | |
Western Human Nutrition Research Center | Recruiting |
Davis, California, United States, 95616 | |
Contact: Marta D Van Loan, Ph.D. 530-752-4160 marta.vanloan@ars.usda.gov | |
Sub-Investigator: Nancy L Keim, Ph.D. | |
Sub-Investigator: Sean H Adams, Ph.D. | |
Sub-Investigator: Michael Spurlock, Ph.D. |
Principal Investigator: | Marta D Van Loan, Ph.D. | USDA, ARS, Western Human Nutrition Research Center |
Responsible Party: | USDA, ARS, Western Human Nutrition Research Center ( Marta Van Loan ) |
Study ID Numbers: | FL49, DMI |
Study First Received: | March 5, 2009 |
Last Updated: | March 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00858312 History of Changes |
Health Authority: | United States: Federal Government |
dairy foods weight loss fat loss metabolic regulation |
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overnutrition Overweight |
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overnutrition Overweight |