- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00858312
Dairy Foods and Weight Loss
April 25, 2019 updated by: USDA, Western Human Nutrition Research Center
Role of Dairy Foods to Enhance Central Fat and Weight Loss With Moderate Energy Restriction in Overweight and Obesity Individuals
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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:
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Davis, California, United States, 95616
- Western Human Nutrition Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body mass index (BMI) 28 -3 4.9 kg/m2
- Age 20-45 years for females, age 20-50 for males
- Low calcium diet (determined by food frequency and diet history): < 1 serving of dairy foods and total dietary Ca intake from all sources not to exceed 600 mg/d .
- No more than 3 kg weight loss during past three months
- Negative pregnancy test at entry prior to DXA and abdominal CT scan; pregnancy testing will be repeated done at 6 weeks of diet intervention to insure that women do not become pregnant during the energy restriction period. Should a woman become pregnant she will be dismissed from the protocol. Pregnancy testing will also be done at the end of the study prior to DXA and abdominal CT scans
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.
- Type II diabetes requiring the use of any oral anti-diabetic agent and/or insulin (because of confounding effects on body weight regulation).
- Fasting glucose > 110 mg/dl.
- Adverse response to study foods (lactose intolerance, dairy intolerance, dairy allergy; this will be determined by self-report.
- High calcium diet (determined by food frequency and diet history): Greater than 600 mg calcium per day from all sources (Ca supplements, dairy foods and other dietary sources).
- History or presence of significant metabolic disease which could impact on the results of the study (i.e. endocrine, hepatic, renal disease).
- Use of hypertension or lipid altering medications.
- Resting blood pressure > 160/100 mg/Hg
- Total cholesterol > 300mg/dl or triglyceride value > 400 mg/dl or LDL > 160 mg/dl.
- History of eating disorder
- Presence of active gastrointestinal disorders such as malabsorption syndromes
- Pregnancy or lactation
- Use of obesity pharmacotherapeutic agents within the last 12 weeks
- Use of over-the-counter anti-obesity agents (e.g. those containing phenylpropanolamine, ephedrine and/or caffeine) within the last 12 weeks
- Use of calcium supplements in the past 12 weeks
- Recent (past four weeks) initiation of an exercise program
- Recent (past twelve weeks) initiation of hormonal birth control or change in hormonal birth control regimen
- Use of tobacco products.
- Exercise more than 30 minutes/day - greater than this may influence substrate utilization.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Diet with 3-4 servings of dairy-rich foods/day
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12 week energy restriction with 3-4 servings of dairy foods/day.
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Placebo Comparator: 2
Low Dairy < 1 serving of dairy food/day
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less than 1 serving of dairy foods per day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body weight
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Weight measured in kg
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measured at end of run-in diet and after 12 weeks of study diet
|
Change in body fat
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Total body fat assessed using dual energy X-ray absorptiometry (DXA)
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measured at end of run-in diet and after 12 weeks of study diet
|
Change in intra-abdominal adipose tissue (IAAT)
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Intra-abdominal adipose tissue IAAT volume measured in cubic centimeters using computed tomography (CT) transabdominal slices
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measured at end of run-in diet and after 12 weeks of study diet
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in subcutaneous adipose cell number and size
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Subcutaneous adipose tissue samples obtained by needle biopsy prepared for histological examination of cell number and size in square micrometers (uM2)
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measured at end of run-in diet and after 12 weeks of study diet
|
Change in subcutaneous adipose tissue inflammation
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Subcutaneous adipose tissue samples obtained by needle biopsy were prepared for histological examination of the number of macrophages.
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measured at end of run-in diet and after 12 weeks of study diet
|
Change in subcutaneous adipose tissue gene expression
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Subcutaneous adipose tissue samples obtained by needle biopsy were prepared for RNA extraction
|
measured at end of run-in diet and after 12 weeks of study diet
|
Change in insulin
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Serum insulin concentration (pmol/L) measured using multiplex technology.
|
measured at end of run-in diet and after 12 weeks of study diet
|
Change in glucose
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Plasma glucose concentration (mmol/L) measured using standard clinical methods
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measured at end of run-in diet and after 12 weeks of study diet
|
Change in total cholesterol
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Serum cholesterol concentration (mmol/L) measured using standard clinical methods
|
measured at end of run-in diet and after 12 weeks of study diet
|
Change in low density lipoprotein (LDL) cholesterol
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Serum LDL cholesterol concentration (mmol/L) measured using standard clinical methods
|
measured at end of run-in diet and after 12 weeks of study diet
|
Change in high density lipoprotein (HDL) cholesterol
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Serum HDL cholesterol concentration (mmol/L) measured using standard clinical methods
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measured at end of run-in diet and after 12 weeks of study diet
|
Change in vitamin D (calciferol) metabolites
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Serum 25-OH Vitamin D (nmol/L) and 1,25 (OH)2 vitamin D concentration (pmol/L) measured using radioimmunoassay (RIA)
|
measured at end of run-in diet and after 12 weeks of study diet
|
Change in leptin
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Serum leptin concentration (ng/ml) measured using multiplex technology.
|
measured at end of run-in diet and after 12 weeks of study diet
|
Change in adiponectin
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Serum adiponectin concentration (ug/mL) measured using multiplex technology.
|
measured at end of run-in diet and after 12 weeks of study diet
|
Change in inflammatory cytokines
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Serum inflammatory cytokine concentration (pg/mL) measured using multiplex technology.
|
measured at end of run-in diet and after 12 weeks of study diet
|
Change in high sensitivity C-reactive protein (hs-CRP)
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Serum hs-CRP concentration (mg/L) measured using immunoassay
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measured at end of run-in diet and after 12 weeks of study diet
|
Change in amylin
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
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Serum amylin concentration measured using multiplex technology.
|
measured at end of run-in diet and after 12 weeks of study diet
|
Change in peptide-YY (PYY)
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Serum PYY concentration measured using multiplex technology.
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measured at end of run-in diet and after 12 weeks of study diet
|
Change in cholecystokinin (CCK)
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Serum CCK concentration measured using radioimmunoassay
|
measured at end of run-in diet and after 12 weeks of study diet
|
Change in glucagon like peptide-1 (GLP-1)
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Serum GLP-1 concentration measured using multiplex technology.
|
measured at end of run-in diet and after 12 weeks of study diet
|
Change in gastric inhibitory peptide (GIP)
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Serum GIP concentration measured using multiplex technology.
|
measured at end of run-in diet and after 12 weeks of study diet
|
Change in sun exposure
Time Frame: measured twice per week for 12 consecutive weeks of study diet
|
Sun exposure was estimated from a personal diary kept weekly for recording time outdoors in hourly increments from 7 am to 7 pm combined with a clothing and sunscreen use standard key.
Ultraviolet B (UVB) data was collected from various regional climate stations enrolled in the USDA UVB Monitoring Research Program (UVMRP).
|
measured twice per week for 12 consecutive weeks of study diet
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Change in skin reflectance
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Spectrophotometric measure of skin pigmentation for assessment of vitamin D status
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measured at end of run-in diet and after 12 weeks of study diet
|
Change in salivary cortisol in response to a meal
Time Frame: 15 minutes before, and 30, 45 and 60 min after lunch
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Cortisol concentration measure by high sensitivity enzyme linked immunoassay (nmol/L)
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15 minutes before, and 30, 45 and 60 min after lunch
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Change in salivary cortisol in response to a buffet
Time Frame: before and 30 min after buffet
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Cortisol concentration measure by high sensitivity enzyme linked immunoassay (nmol/L)
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before and 30 min after buffet
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Change in salivary cortisol in response to weight loss
Time Frame: measured at end of run-in diet and after 12 weeks of study diet
|
Cortisol concentration measure by high sensitivity enzyme linked immunoassay (nmol/L)
|
measured at end of run-in diet and after 12 weeks of study diet
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marta D Van Loan, Ph.D., USDA, ARS, Western Human Nutrition Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Van Loan MD, Keim NL, Adams SH, Souza E, Woodhouse LR, Thomas A, Witbracht M, Gertz ER, Piccolo B, Bremer AA, Spurlock M. Dairy Foods in a Moderate Energy Restricted Diet Do Not Enhance Central Fat, Weight, and Intra-Abdominal Adipose Tissue Losses nor Reduce Adipocyte Size or Inflammatory Markers in Overweight and Obese Adults: A Controlled Feeding Study. J Obes. 2011;2011:989657. doi: 10.1155/2011/989657. Epub 2011 Sep 14.
- Witbracht MG, Laugero KD, Van Loan MD, Adams SH, Keim NL. Performance on the Iowa Gambling Task is related to magnitude of weight loss and salivary cortisol in a diet-induced weight loss intervention in overweight women. Physiol Behav. 2012 May 15;106(2):291-7. doi: 10.1016/j.physbeh.2011.04.035. Epub 2011 Apr 30.
- Witbracht MG, Van Loan M, Adams SH, Keim NL, Laugero KD. Dairy food consumption and meal-induced cortisol response interacted to influence weight loss in overweight women undergoing a 12-week, meal-controlled, weight loss intervention. J Nutr. 2013 Jan;143(1):46-52. doi: 10.3945/jn.112.166355. Epub 2012 Nov 28.
- Piccolo BD, Dolnikowski G, Seyoum E, Thomas AP, Gertz ER, Souza EC, Woodhouse LR, Newman JW, Keim NL, Adams SH, Van Loan MD. Association between subcutaneous white adipose tissue and serum 25-hydroxyvitamin D in overweight and obese adults. Nutrients. 2013 Aug 26;5(9):3352-66. doi: 10.3390/nu5093352.
- Piccolo BD, Keim NL, Fiehn O, Adams SH, Van Loan MD, Newman JW. Habitual physical activity and plasma metabolomic patterns distinguish individuals with low vs. high weight loss during controlled energy restriction. J Nutr. 2015 Apr;145(4):681-90. doi: 10.3945/jn.114.201574. Epub 2015 Jan 28.
- Krishnan S, Adams SH, Witbracht MG, Woodhouse LR, Piccolo BD, Thomas AP, Souza EC, Horn WF, Gertz ER, Van Loan MD, Keim NL. Weight Loss, but Not Dairy Composition of Diet, Moderately Affects Satiety and Postprandial Gut Hormone Patterns in Adults. J Nutr. 2021 Jan 4;151(1):245-254. doi: 10.1093/jn/nxaa327.
- Piccolo BD, Hall LM, Stephensen CB, Gertz ER, Van Loan MD. Circulating 25-Hydroxyvitamin D Concentrations in Overweight and Obese Adults Are Explained by Sun Exposure, Skin Reflectance, and Body Composition. Curr Dev Nutr. 2019 May 27;3(7):nzz065. doi: 10.1093/cdn/nzz065. eCollection 2019 Jul.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2006
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
March 5, 2009
First Submitted That Met QC Criteria
March 6, 2009
First Posted (Estimate)
March 9, 2009
Study Record Updates
Last Update Posted (Actual)
April 29, 2019
Last Update Submitted That Met QC Criteria
April 25, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FL49
- DMI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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