- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00948038
Dairy Modulation of Oxidative and Inflammatory Stress in Overweight and Obese Subjects
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37996
- The University of Tennessee
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Soy
Soy-based supplement to normal diet
|
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
|
Milk-based smoothie containing 170 kcal, 10 g protein, 1 g fat, 30 g carbohydrate adn 350 mg Ca.
Three consumed each day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma malondialdehyde
Time Frame: 28 days
|
28 days
|
Plasma 8-isoprostane F2-alpha
Time Frame: 28 days
|
28 days
|
Plasma tumor necrosis factor alpha
Time Frame: 28 days
|
28 days
|
plasma interleukin 6
Time Frame: 28 days
|
28 days
|
Plasma C-reactive protein
Time Frame: 28 days
|
28 days
|
Plasma MCP-1
Time Frame: 28-days
|
28-days
|
Plasma interleukin 15
Time Frame: 28 days
|
28 days
|
Plasma adiponectin
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma lipids
Time Frame: 28 days
|
28 days
|
Plasma insulin
Time Frame: 28 days
|
28 days
|
vitamin D
Time Frame: 28 days
|
28 days
|
Body composition
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMI-033
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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