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Oxidative StressNCT01266330

Dairy Attenuation of Metabolic Disease

A study testing Low Dairy and Adequate Dairy in people with Oxidative Stress and Inflammation, run by University of Tennessee at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Oxidative Stress, Inflammation
What is being tested?
Low Dairy and Adequate Dairy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Jun 2008to Jan 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • • 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)
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  • 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

Who cannot join

  • • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The University of Tennessee Nutrition and Metabolic Research Laboratory

    Knoxville, Tennessee, 37996

Other trials in United States

About this study

Official title: Dairy Attenuation of Oxidative and Inflammatory Stress in Metabolic Syndrome

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)

Read the 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).

Being tested
Low Dairy, Adequate Dairy
Keywords
dairy, inflammation, reactive oxygen species, oxidative stress, body composition
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low DairyDietary supplement

    Less than 0.5 standard servings of dairy products per day

  • Adequate DairyDietary supplement

    3.5 standard servings of dairy foods per day

Study groups in NCT01266330
Study groupRoleWhat they receive
Low DairyActive comparator<0.5 standard dairy servings/day
Receives: Dietary Supplement: Low Dairy
Adequate dairyExperimental3.5 standard dairy servings per day
Receives: Dietary Supplement: Adequate Dairy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight

    Measured: 12 weeks

  2. Body composition

    DEXA assessment

    Measured: 12 weeks

  3. Oxidative Stress

    plasma malonaldehyde, 8-isoprostane F2α and oxidized LDL

    Measured: 12 weeks

  4. Inflammatory stress

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

    Measured: 12 weeks

Secondary outcomes (3)
  1. Insulin sensitivituy

    Glucose, insulin and HOMA

    Measured: 12 weeks

  2. Blood pressure

    Measured: 12 weeks

  3. Lipids

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2010 (estimated)
  2. Study startJun 2008
  3. Primary completionApr 2009
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01266330
Sponsor's protocol ID
R011770040
Status last verified
Dec 2010
First submitted
22 Dec 2010
Last updated
24 Dec 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21715516

Questions about this trial

What is this clinical trial studying?

A study testing Low Dairy and Adequate Dairy in people with Oxidative Stress and Inflammation, run by University of Tennessee at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01266330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2010.

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