Dairy Modulation of Oxidative and Inflammatory Stress in Overweight and Obese Subjects

This study has been completed.
Sponsor:
Collaborator:
Dairy Management Inc.
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00948038
First received: July 28, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

The objective of this study is to determine the acute effects of a dairy supplement compared to a soy supplement on oxidative and inflammatory stress in overweight and obese subjects in the absence of any changes in adiposity.


Condition Intervention
Obesity
Overweight
Dietary Supplement: Milk
Dietary Supplement: Soy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Plasma malondialdehyde [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Plasma 8-isoprostane F2-alpha [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Plasma tumor necrosis factor alpha [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • plasma interleukin 6 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Plasma C-reactive protein [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Plasma MCP-1 [ Time Frame: 28-days ] [ Designated as safety issue: No ]
  • Plasma interleukin 15 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Plasma adiponectin [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma lipids [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Plasma insulin [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • vitamin D [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2007
Study Completion Date: May 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Soy
Soy-based supplement to normal diet
Dietary Supplement: Soy
Soy-based smoothie containing 170 kcal, 10 g protein, 1 g fat, 30 g carbohydrate and 30 mg Ca. Three consumed each day for 28 days,
Experimental: Milk
Milk-based supplement to normal diet
Dietary Supplement: Milk
Milk-based smoothie containing 170 kcal, 10 g protein, 1 g fat, 30 g carbohydrate adn 350 mg Ca. Three consumed each day.

Detailed Description:

Obesity is associated with sub-clinical chronic oxidative and inflammatory stress, both of which are major contributors to obesity-associated co-morbidities. Calcitriol (1, 25-(OH)2-D3) regulates adipocyte lipid metabolism, while dietary calcium inhibits obesity by suppression of calcitriol. We have recently shown calcitriol to increase oxidative stress and to stimulate the expression and release of inflammatory cytokines, while inhibiting the expression and release of anti-inflammatory cytokines. We have also shown that inhibition of calcitriol with high calcium diets decreases both adipose tissue and systemic oxidative and inflammatory stress in a mouse model of obesity. Moreover, dairy exerted a greater effect on both oxidative and inflammatory stress. These mice also exhibited significant reductions in adiposity, which could lead to confounding, as this reduction will independently reduce oxidative and inflammatory stress. However, the supporting cellular/mechanistic data indicate an effect which is independent of adiposity reduction. Consequently, we propose that low calcium diets exacerbate oxidative and inflammatory stress and that high dairy diets can attenuate both independently of changes in adiposity, thereby significantly reducing the risk of obesity-associated co-morbidities. Accordingly, the objective of this study is to determine the acute effects of a dairy-rich diet on oxidative and inflammatory stress in overweight and obese subjects in the absence of any changes in adiposity.

Twenty subjects (10 obese and 10 overweight) will undergo a randomized crossover study of low dairy and high dairy eucaloric diets. Each dietary period will be four weeks, and the two dietary periods will be separated by a four-week washout period. Primary outcomes will be circulating indices of oxidative stress and of inflammation. Secondary outcomes include blood pressure, circulating glucose, insulin, lipids, calcium-regulatory hormones and body composition.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index (BMI) 25-29.9 (n=10); 30-34.9 kg/m2 (n=10)
  • Age 18-50 years
  • Weight stable: no more than 3 kg weight loss during past three months

Exclusion Criteria:

  • BMI < 25 or >35
  • Type II diabetes requiring the use of any oral antidiabetic agent and/or insulin (because of confounding effects on ROS)
  • Adverse response to study foods (lactose intolerance, dairy intolerance, dairy allergy); this will be determined by self-report.
  • history or presence of significant metabolic disease which could impact on the results of the study (i.e. endocrine, hepatic, renal disease)
  • history of eating disorder
  • presence of active gastrointestinal disorders such as malabsorption syndromes
  • pregnancy or lactation
  • use of obesity pharmacotherapeutic agents within the last 6 months
  • use of over-the-counter anti-obesity agents (e.g. those containing phenylpropanalamine, ephedrine and/or caffeine) within the last 6 months
  • Recent (current or past 12 weeks) use of any psychotropic medication
  • Recent (past four weeks) initiation of an exercise program
  • Recent (past twelve weeks) initiation of hormone replacement therapy or change in HRT regimen
  • Recent (past twelve weeks) initiation of hormonal birth control or change in hormonal birth control regimen
  • Recent (current or past 12 weeks) history of smoking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948038

Locations
United States, Tennessee
The University of Tennessee
Knoxville, Tennessee, United States, 37996
Sponsors and Collaborators
University of Tennessee
Dairy Management Inc.
  More Information

No publications provided

Responsible Party: Michael B. Zemel, Professor, The University of Tennessee
ClinicalTrials.gov Identifier: NCT00948038     History of Changes
Other Study ID Numbers: DMI-033
Study First Received: July 28, 2009
Last Updated: July 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Inflammation
Oxidative stress

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014