Overweight and ObesityNCT00858312
Dairy Foods and Weight Loss
A study testing high dairy diet and Low Dairy in people with Overweight and Obesity, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- high dairy diet and Low Dairy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: 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.
Read the 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
- Overweight and Obesity
- Being tested
- high dairy diet, Low Dairy
- Keywords
- dairy foods, weight loss, fat loss, metabolic regulation
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high dairy dietOther
12 week energy restriction with 3-4 servings of dairy foods/day.
Low DairyOther
less than 1 serving of dairy foods per day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Diet with 3-4 servings of dairy-rich foods/day Receives: Other: high dairy diet |
| 2 | Placebo comparator | Low Dairy < 1 serving of dairy food/day Receives: Other: Low Dairy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Weight measured in kg
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in body fat
Total body fat assessed using dual energy X-ray absorptiometry (DXA)
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in intra-abdominal adipose tissue (IAAT)
Intra-abdominal adipose tissue IAAT volume measured in cubic centimeters using computed tomography (CT) transabdominal slices
Measured: measured at end of run-in diet and after 12 weeks of study diet
Secondary outcomes (23)
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)
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in subcutaneous adipose tissue inflammation
Subcutaneous adipose tissue samples obtained by needle biopsy were prepared for histological examination of the number of macrophages.
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in subcutaneous adipose tissue gene expression
Subcutaneous adipose tissue samples obtained by needle biopsy were prepared for RNA extraction
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in insulin
Serum insulin concentration (pmol/L) measured using multiplex technology.
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in glucose
Plasma glucose concentration (mmol/L) measured using standard clinical methods
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in total cholesterol
Serum cholesterol concentration (mmol/L) measured using standard clinical methods
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in low density lipoprotein (LDL) cholesterol
Serum LDL cholesterol concentration (mmol/L) measured using standard clinical methods
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in high density lipoprotein (HDL) cholesterol
Serum HDL cholesterol concentration (mmol/L) measured using standard clinical methods
Measured: measured at end of run-in diet and after 12 weeks of study diet
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)
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in leptin
Serum leptin concentration (ng/ml) measured using multiplex technology.
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in adiponectin
Serum adiponectin concentration (ug/mL) measured using multiplex technology.
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in inflammatory cytokines
Serum inflammatory cytokine concentration (pg/mL) measured using multiplex technology.
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in high sensitivity C-reactive protein (hs-CRP)
Serum hs-CRP concentration (mg/L) measured using immunoassay
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in amylin
Serum amylin concentration measured using multiplex technology.
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in peptide-YY (PYY)
Serum PYY concentration measured using multiplex technology.
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in cholecystokinin (CCK)
Serum CCK concentration measured using radioimmunoassay
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in glucagon like peptide-1 (GLP-1)
Serum GLP-1 concentration measured using multiplex technology.
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in gastric inhibitory peptide (GIP)
Serum GIP concentration measured using multiplex technology.
Measured: measured at end of run-in diet and after 12 weeks of study diet
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).
Measured: measured twice per week for 12 consecutive weeks of study diet
Change in skin reflectance
Spectrophotometric measure of skin pigmentation for assessment of vitamin D status
Measured: measured at end of run-in diet and after 12 weeks of study diet
Change in salivary cortisol in response to a meal
Cortisol concentration measure by high sensitivity enzyme linked immunoassay (nmol/L)
Measured: 15 minutes before, and 30, 45 and 60 min after lunch
Change in salivary cortisol in response to a buffet
Cortisol concentration measure by high sensitivity enzyme linked immunoassay (nmol/L)
Measured: before and 30 min after buffet
Change in salivary cortisol in response to weight loss
Cortisol concentration measure by high sensitivity enzyme linked immunoassay (nmol/L)
Measured: measured at end of run-in diet and after 12 weeks of study diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startOct 2006
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- Iowa State University
- Responsible party
- Sponsor
- Investigators
- Marta D Van Loan, Ph.D., Principal investigator, USDA, ARS, Western Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858312
- Sponsor's protocol ID
- FL49
- Other IDs
- DMI
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2009
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21941636Witbracht 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.
PubMed 21565212Witbracht 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.
PubMed 23190756Piccolo 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.
PubMed 24067385Piccolo 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.
PubMed 25833772Krishnan 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.
PubMed 33245130Piccolo 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.
PubMed 31304455
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dairy Foods to Enhance Central Fat and Weight Loss With Moderate Energy Restriction in Overweight and Obesity Individuals
- ClinicalTrials.gov ID
- NCT00858312
- Acronym / sponsor ID
- FL49
- Conditions
- Overweight and Obesity
- Keywords
- dairy foods, weight loss, fat loss, metabolic regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- Iowa State University
- Study start
- Oct 2006 (actual)
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: high dairy dietDiet with 3-4 servings of dairy-rich foods/day |
| 2 | Placebo comparator | Other: Low DairyLow Dairy < 1 serving of dairy food/day |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high dairy diet12 week energy restriction with 3-4 servings of dairy foods/day. | Other | 1 |
| Low Dairyless than 1 serving of dairy foods per day. | Other | 2 |
Primary outcome
Change in body weight
Time frame: measured at end of run-in diet and after 12 weeks of study diet
Weight measured in kg
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)
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
23 secondary outcomes
Change in subcutaneous adipose cell number and size
Time frame: 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
Change in subcutaneous adipose tissue gene expression
Time frame: 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
Change in glucose
Time frame: 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
Change in low density lipoprotein (LDL) cholesterol
Time frame: 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
Change in vitamin D (calciferol) metabolites
Time frame: 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
Change in adiponectin
Time frame: 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
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
Change in amylin
Time frame: 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
Change in cholecystokinin (CCK)
Time frame: 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
Change in gastric inhibitory peptide (GIP)
Time frame: 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
Change in skin reflectance
Time frame: 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
Change in salivary cortisol in response to a buffet
Time frame: before and 30 min after buffet
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Background: PubMed 21941636Van 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.
- Background: PubMed 21565212Witbracht 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.
- Background: PubMed 23190756Witbracht 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.
- Background: PubMed 24067385Piccolo 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.
- Background: PubMed 25833772Piccolo 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.
- Derived from this study: PubMed 33245130Krishnan 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.
- Derived from this study: PubMed 31304455Piccolo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta D Van Loan, Ph.D. principal investigator
USDA, ARS, Western Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high dairy diet and Low Dairy in people with Overweight and Obesity, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: measured at end of run-in diet and after 12 weeks of study diet). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00858312, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.