Dairy Attenuation of Metabolic Disease

NCT ID: NCT01266330

Last Updated: 2010-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-01-31

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)

Detailed Description

This study is designed to determine the effects of a dairy-rich diet on oxidative and inflammatory stress in metabolic syndrome patients in the presence and absence of obesity. Forty overweight and obese subjects (BMI 25-39.9) with metabolic syndrome as defined by NCEP ATP III criteria will be randomized to inadequate (0-0.5 daily serving) or adequate (3.5 servings) dairy diets in the presence of a eucaloric weight maintenance diet for 12 weeks. All subjects will undergo a 14-day lead-in period to establish a stable baseline of dietary and physiological measures (described below), followed by the 12-week intervention period. Baseline dietary assessments will be conducted by the project dietitian during the two-week lead-in period which will be used to provide an initial estimate of a maintenance level of caloric intake. This will be refined by calculating energy needs using DRI equations for calculation of age- and physical activity (PA) adjusted total energy expenditure (TEE) for men and women. Energy requirements will be confirmed via measurement of resting metabolic rate via indirect calorimetry.

Subjects will be given diets isocaloric to those consumed during the lead-in period, with macronutrient and fiber levels maintained equivalent at levels approximating the estimated U.S. average (described in Diets section). Subjects on the inadequate dairy diets will be assigned diets containing < 600 mg Ca/day and <0.5 daily serving of dairy foods, and subjects on the adequate dairy diets will be assigned diets containing 1200 - 1400 mg Ca/day and 3.5 daily servings of dairy (milk, yogurt, hard cheese). Two of the three dairy servings consumed daily by those on the high dairy diet will be milk and/or yogurt to ensure sufficient consumption of whey proteins. All subjects will be provided individual instruction, counseling and assessment from the study dietitian regarding dietary adherence and the development and reinforcement of strategies for continued success, and diets will be monitored weekly. Physical activity will be assessed using pedometer counts and maintained at approximately pre-study levels throughout the study. Pedometer counts will be recorded daily for the 14-day lead-in period and the value averaged to provide a pre-study baseline. Subjects will be asked to maintain the same level of activity (plus or minus 500 steps/day) and will use pedometers for self-assessment. Pedometer counts will be recorded and provided to the study staff on a weekly basis, along with the diet records.

Body weight, waist circumference, and blood pressure will be measured weekly and body composition (via dual X-ray absorptiometry) will be measured at weeks 0, 4 and 12 of the dietary intervention. Resting metabolic rate and respiratory quotient will be assessed at weeks 0 and 12. Oxidative burden will be assessed by measurement of plasma malonaldehyde, 8-isoprostane F2α and oxidized LDL at weeks 0, 1, 4 and 12, 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 the same time intervals. Glucose tolerance, HOMAIR, fasting plasma lipids, PTH and 1,25-(OH)2-D levels will be determined at the same time intervals (0, 4, and 12 weeks). All data will be analyzed via two-factor multivariate analysis of variance (MANOVA).

Conditions

Oxidative Stress; Inflammation

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Low Dairy

\<0.5 standard dairy servings/day

Group Type: ACTIVE_COMPARATOR

Low Dairy

Intervention Type: DIETARY_SUPPLEMENT

Less than 0.5 standard servings of dairy products per day

Adequate dairy

3.5 standard dairy servings per day

Group Type: EXPERIMENTAL

Adequate Dairy

Intervention Type: DIETARY_SUPPLEMENT

3.5 standard servings of dairy foods per day

Interventions

Low Dairy

Less than 0.5 standard servings of dairy products per day

Intervention Type: DIETARY_SUPPLEMENT

Adequate Dairy

3.5 standard servings of dairy foods per day

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• • 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

Exclusion Criteria

• • 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tennessee

OTHER

Sponsor Role: lead

Responsible Party

The University of Tennessee

Principal Investigators

Michael B. Zemel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Tennessee

Locations

The University of Tennessee Nutrition and Metabolic Research Laboratory

Knoxville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21715516 (View on PubMed)

Other Identifiers

R011770040

Identifier Type: -

Identifier Source: org_study_id