MedTrace Logo

Dairy Attenuation of Metabolic Disease

NCT01266330 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-12-24

No results posted yet for this study

Summary

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)

Conditions

Interventions

DIETARY_SUPPLEMENT

Low Dairy

Less than 0.5 standard servings of dairy products per day

DIETARY_SUPPLEMENT

Adequate Dairy

3.5 standard servings of dairy foods per day

Sponsors & Collaborators

  • University of Tennessee

    lead OTHER

Principal Investigators

  • Michael B. Zemel, Ph.D. · The University of Tennessee

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-04-30
Completion
2010-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01266330 on ClinicalTrials.gov