Dairy Foods and Weight Loss
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high dairy diet
Low Dairy
Sponsored by
About this trial
This is an interventional basic science trial for Overweight and Obesity focused on measuring dairy foods, weight loss, fat loss, metabolic regulation
Eligibility Criteria
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.
Sites / Locations
- Western Human Nutrition Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Diet with 3-4 servings of dairy-rich foods/day
Low Dairy < 1 serving of dairy food/day
Outcomes
Primary Outcome Measures
Change in body weight
Weight measured in kg
Change in body fat
Total body fat assessed using dual energy X-ray absorptiometry (DXA)
Change in intra-abdominal adipose tissue (IAAT)
Intra-abdominal adipose tissue IAAT volume measured in cubic centimeters using computed tomography (CT) transabdominal slices
Secondary Outcome Measures
Change in subcutaneous adipose cell number and size
Subcutaneous adipose tissue samples obtained by needle biopsy prepared for histological examination of cell number and size in square micrometers (uM2)
Change in subcutaneous adipose tissue inflammation
Subcutaneous adipose tissue samples obtained by needle biopsy were prepared for histological examination of the number of macrophages.
Change in subcutaneous adipose tissue gene expression
Subcutaneous adipose tissue samples obtained by needle biopsy were prepared for RNA extraction
Change in insulin
Serum insulin concentration (pmol/L) measured using multiplex technology.
Change in glucose
Plasma glucose concentration (mmol/L) measured using standard clinical methods
Change in total cholesterol
Serum cholesterol concentration (mmol/L) measured using standard clinical methods
Change in low density lipoprotein (LDL) cholesterol
Serum LDL cholesterol concentration (mmol/L) measured using standard clinical methods
Change in high density lipoprotein (HDL) cholesterol
Serum HDL cholesterol concentration (mmol/L) measured using standard clinical methods
Change in vitamin D (calciferol) metabolites
Serum 25-OH Vitamin D (nmol/L) and 1,25 (OH)2 vitamin D concentration (pmol/L) measured using radioimmunoassay (RIA)
Change in leptin
Serum leptin concentration (ng/ml) measured using multiplex technology.
Change in adiponectin
Serum adiponectin concentration (ug/mL) measured using multiplex technology.
Change in inflammatory cytokines
Serum inflammatory cytokine concentration (pg/mL) measured using multiplex technology.
Change in high sensitivity C-reactive protein (hs-CRP)
Serum hs-CRP concentration (mg/L) measured using immunoassay
Change in amylin
Serum amylin concentration measured using multiplex technology.
Change in peptide-YY (PYY)
Serum PYY concentration measured using multiplex technology.
Change in cholecystokinin (CCK)
Serum CCK concentration measured using radioimmunoassay
Change in glucagon like peptide-1 (GLP-1)
Serum GLP-1 concentration measured using multiplex technology.
Change in gastric inhibitory peptide (GIP)
Serum GIP concentration measured using multiplex technology.
Change in sun exposure
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).
Change in skin reflectance
Spectrophotometric measure of skin pigmentation for assessment of vitamin D status
Change in salivary cortisol in response to a meal
Cortisol concentration measure by high sensitivity enzyme linked immunoassay (nmol/L)
Change in salivary cortisol in response to a buffet
Cortisol concentration measure by high sensitivity enzyme linked immunoassay (nmol/L)
Change in salivary cortisol in response to weight loss
Cortisol concentration measure by high sensitivity enzyme linked immunoassay (nmol/L)
Full Information
NCT ID
NCT00858312
First Posted
March 5, 2009
Last Updated
April 25, 2019
Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
Iowa State University
1. Study Identification
Unique Protocol Identification Number
NCT00858312
Brief Title
Dairy Foods and Weight Loss
Official Title
Role of Dairy Foods to Enhance Central Fat and Weight Loss With Moderate Energy Restriction in Overweight and Obesity Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2006 (Actual)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
Iowa State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
dairy foods, weight loss, fat loss, metabolic regulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Diet with 3-4 servings of dairy-rich foods/day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Low Dairy < 1 serving of dairy food/day
Intervention Type
Other
Intervention Name(s)
high dairy diet
Intervention Description
12 week energy restriction with 3-4 servings of dairy foods/day.
Intervention Type
Other
Intervention Name(s)
Low Dairy
Intervention Description
less than 1 serving of dairy foods per day.
Primary Outcome Measure Information:
Title
Change in body weight
Description
Weight measured in kg
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in body fat
Description
Total body fat assessed using dual energy X-ray absorptiometry (DXA)
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in intra-abdominal adipose tissue (IAAT)
Description
Intra-abdominal adipose tissue IAAT volume measured in cubic centimeters using computed tomography (CT) transabdominal slices
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Secondary Outcome Measure Information:
Title
Change in subcutaneous adipose cell number and size
Description
Subcutaneous adipose tissue samples obtained by needle biopsy prepared for histological examination of cell number and size in square micrometers (uM2)
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in subcutaneous adipose tissue inflammation
Description
Subcutaneous adipose tissue samples obtained by needle biopsy were prepared for histological examination of the number of macrophages.
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in subcutaneous adipose tissue gene expression
Description
Subcutaneous adipose tissue samples obtained by needle biopsy were prepared for RNA extraction
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in insulin
Description
Serum insulin concentration (pmol/L) measured using multiplex technology.
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in glucose
Description
Plasma glucose concentration (mmol/L) measured using standard clinical methods
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in total cholesterol
Description
Serum cholesterol concentration (mmol/L) measured using standard clinical methods
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in low density lipoprotein (LDL) cholesterol
Description
Serum LDL cholesterol concentration (mmol/L) measured using standard clinical methods
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in high density lipoprotein (HDL) cholesterol
Description
Serum HDL cholesterol concentration (mmol/L) measured using standard clinical methods
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in vitamin D (calciferol) metabolites
Description
Serum 25-OH Vitamin D (nmol/L) and 1,25 (OH)2 vitamin D concentration (pmol/L) measured using radioimmunoassay (RIA)
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in leptin
Description
Serum leptin concentration (ng/ml) measured using multiplex technology.
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in adiponectin
Description
Serum adiponectin concentration (ug/mL) measured using multiplex technology.
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in inflammatory cytokines
Description
Serum inflammatory cytokine concentration (pg/mL) measured using multiplex technology.
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in high sensitivity C-reactive protein (hs-CRP)
Description
Serum hs-CRP concentration (mg/L) measured using immunoassay
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in amylin
Description
Serum amylin concentration measured using multiplex technology.
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in peptide-YY (PYY)
Description
Serum PYY concentration measured using multiplex technology.
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in cholecystokinin (CCK)
Description
Serum CCK concentration measured using radioimmunoassay
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in glucagon like peptide-1 (GLP-1)
Description
Serum GLP-1 concentration measured using multiplex technology.
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in gastric inhibitory peptide (GIP)
Description
Serum GIP concentration measured using multiplex technology.
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in sun exposure
Description
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).
Time Frame
measured twice per week for 12 consecutive weeks of study diet
Title
Change in skin reflectance
Description
Spectrophotometric measure of skin pigmentation for assessment of vitamin D status
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
Title
Change in salivary cortisol in response to a meal
Description
Cortisol concentration measure by high sensitivity enzyme linked immunoassay (nmol/L)
Time Frame
15 minutes before, and 30, 45 and 60 min after lunch
Title
Change in salivary cortisol in response to a buffet
Description
Cortisol concentration measure by high sensitivity enzyme linked immunoassay (nmol/L)
Time Frame
before and 30 min after buffet
Title
Change in salivary cortisol in response to weight loss
Description
Cortisol concentration measure by high sensitivity enzyme linked immunoassay (nmol/L)
Time Frame
measured at end of run-in diet and after 12 weeks of study diet
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta D Van Loan, Ph.D.
Organizational Affiliation
USDA, ARS, Western Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21941636
Citation
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.
Results Reference
background
PubMed Identifier
21565212
Citation
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.
Results Reference
background
PubMed Identifier
23190756
Citation
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.
Results Reference
background
PubMed Identifier
24067385
Citation
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.
Results Reference
background
PubMed Identifier
25833772
Citation
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.
Results Reference
background
PubMed Identifier
33245130
Citation
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.
Results Reference
derived
PubMed Identifier
31304455
Citation
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.
Results Reference
derived
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Dairy Foods and Weight Loss
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