Dairy Attenuation of Metabolic Disease

NCT01266330 | Completed

• 1 other identifier: R011770040
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Oxidative Stress; Inflammation

Keywords

dairy; inflammation; reactive oxygen species; oxidative stress; body composition

Outcome Measures

Primary Outcomes (4)

• Body weight

  12 weeks

• Body composition

  DEXA assessment

  12 weeks

• Oxidative Stress

  plasma malonaldehyde, 8-isoprostane F2α and oxidized LDL

  12 weeks

• Inflammatory stress

  Plasma L-6, IL-15, MCP, C-reactive protein, adiponectin and TNF-α

  12 weeks

Secondary Outcomes (3)

• Insulin sensitivituy

  12 weeks

• Blood pressure

  12 weeks

• Lipids

  12 weeks

Study Arms (2)

Low Dairy

ACTIVE COMPARATOR

\<0.5 standard dairy servings/day

Dietary Supplement: Low Dairy

Adequate dairy

EXPERIMENTAL

3.5 standard dairy servings per day

Dietary Supplement: Adequate Dairy

Interventions

Low Dairy DIETARY_SUPPLEMENT

Less than 0.5 standard servings of dairy products per day

Low Dairy

Adequate Dairy DIETARY_SUPPLEMENT

3.5 standard servings of dairy foods per day

Adequate dairy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

The University of Tennessee Nutrition and Metabolic Research Laboratory

Knoxville, Tennessee, 37996, United States

Location

Related Publications (1)

• Stancliffe RA, Thorpe T, Zemel MB. Dairy attentuates oxidative and inflammatory stress in metabolic syndrome. Am J Clin Nutr. 2011 Aug;94(2):422-30. doi: 10.3945/ajcn.111.013342. Epub 2011 Jun 29.

  PMID: 21715516 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael B. Zemel, Ph.D.

  The University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 24, 2010
• Study Start: June 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: January 1, 2010
• Last Updated: December 24, 2010

Record last verified: 2010-12

Locations

US (1)