Dairy Foods and Weight Loss

NCT00858312 | Completed

• 2 other identifiers: FL49DMI
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

dairy foods; weight loss; fat loss; metabolic regulation

Outcome Measures

Primary Outcomes (3)

• Change in body weight

  Weight measured in kg

  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 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 at end of run-in diet and after 12 weeks of study diet

Secondary Outcomes (23)

• Change in subcutaneous adipose cell number and size

  measured at end of run-in diet and after 12 weeks of study diet

• Change in subcutaneous adipose tissue inflammation

  measured at end of run-in diet and after 12 weeks of study diet

• Change in subcutaneous adipose tissue gene expression

  measured at end of run-in diet and after 12 weeks of study diet

• Change in insulin

  measured at end of run-in diet and after 12 weeks of study diet

• Change in glucose

  measured at end of run-in diet and after 12 weeks of study diet

Study Arms (2)

1

EXPERIMENTAL

Diet with 3-4 servings of dairy-rich foods/day

Other: high dairy diet

2

PLACEBO COMPARATOR

Low Dairy \< 1 serving of dairy food/day

Other: Low Dairy

Interventions

high dairy diet OTHER

12 week energy restriction with 3-4 servings of dairy foods/day.

1

Low Dairy OTHER

less than 1 serving of dairy foods per day.

2

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead
• Iowa State University: collaborator

Study Sites (1)

Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Related Publications (7)

• 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.

  PMID: 21941636 BACKGROUND

• 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.

  PMID: 21565212 BACKGROUND

• 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.

  PMID: 23190756 BACKGROUND

• 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.

  PMID: 24067385 BACKGROUND

• 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.

  PMID: 25833772 BACKGROUND

• 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.

  PMID: 33245130 DERIVED

• 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.

  PMID: 31304455 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Marta D Van Loan, Ph.D.

  USDA, ARS, Western Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 9, 2009
• Study Start: October 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

US (1)