Dairy Attenuation of Metabolic Disease

Completed · Not applicable

Conditions studied: Oxidative Stress, Inflammation

In brief

Forty overweight and obese subjects (BMI 25-39.9) with metabolic syndrome will be randomized to inadequate dairy (\<0.5 serving/day) and adequate dairy (3.5 servings/day) weight maintenance (eucaloric) diets for 12 weeks. Body weight will be measured weekly and body composition (via dual X-ray absorptiometry), insulin sensitivity index, plasma lipids and calcitrophic hormones will be measured at weeks 0, 4 and 12 of the dietary intervention. Oxidative burden will be assessed by measurement of plasma malonaldehyde, 8-isoprostane F2α and oxidized LDL and inflammatory stress will be assessed by measurement of IL-6, IL-15, MCP, C-reactive protein, adiponectin and TNF-α levels in plasma at 0, 1, 4 and 12 weeks). An additional global evaluation of diet-induced changes in cytokines will be conducted using cytokine protein arrays to profile relative changes in 36 additional potentially relevant cytokines. All data will be analyzed via two-factor (diet X obesity status) multivariate analysis of variance (MANOVA)

Key facts

Study ID

NCT01266330

Run by

University of Tennessee

People needed

40

Starts

2008-06-01

Expected to finish

2010-01-01

Last updated by the study team

2010-12-24

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • Diagnosis of metabolic syndrome as defined by NCEP ATP III criteria: Presence of three or more of the following risk determinants:
• Abdominal obesity (This criterion must be met by all obese subjects entered into the study)
• Waist circumference >102 cm for males
• Waist circumference >88 cm for females
• Triglycerides >150 mg/dL
• HDL cholesterol <40 mg/dL (men); < 50 mg/dL (women)
• Blood pressure >130/>85 mm Hg (This criterion must be met by all subjects [overweight and obese] entered into the study).
• Fasting glucose >100 mg/dL
• Body mass index (BMI) 25-39.9
• Age 18-50 years
• Weight stable: no more than 1 kg weight gain or loss during past four weeks

You may not qualify if…

• • BMI < 25 or >40
• 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 3 months
• Chronic use of anti-inflammatory agents within the last four weeks
• Use of antioxidant supplements within the last four weeks
• 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 (past 12-weeks) history of tobacco use

Where it is running

• The University of Tennessee Nutrition and Metabolic Research Laboratory — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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