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Dairy Macronutrient Effects on the Metabolic Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02885935
First Posted: September 1, 2016
Last Update Posted: September 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dairy Research Institute
Information provided by (Responsible Party):
University of Arkansas
  Purpose
The investigators examined the effects of 4-week dietary protein intake in mixed meals at two levels of protein amount on whole body glucose metabolisms in older adults with metabolic syndrome.

Condition Intervention
Metabolic Syndrome Other: Recommended protein intake Other: Elevated protein intake

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Changes in rate of glucose disappearance [ Time Frame: Change from baseline and after 4weeks of dietary intervention ]
    Rate of glucose disappearance from plasma to body tissues is a measure of whole body insulin sensitivity


Enrollment: 12
Study Start Date: April 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Recommended protein intake
Subjects consumed diets with a macronutrient distribution of 10% protein, 55% carbohydrates, and 35% fat for 4 weeks.
Other: Recommended protein intake
Recommended protein intake diet contained 10% protein, 55% carbohydrate,and 35 % fat.
Experimental: Elevated protein intake
Subjects consumed diets with a macronutrient distribution of 20% protein, 45% carbohydrates and 35% fat for 4 weeks.
Other: Elevated protein intake
Recommended protein intake diet contained 20% protein, 45% carbohydrate,and 35 % fat.

Detailed Description:
The investigators investigated changes in insulin sensitivity before and after 4 weeks of dietary intervention and control in subjects with metabolic syndrome. Two groups of subjects were studied before and after a weight maintenance diet. Group 1 was fed a common American diet with a macronutrient distribution of 10% protein, 55% carbohydrates, and 35% fat. Group 2 consumed a higher protein diet (20%; 1.4 g/kg/d of protein). Carbohydrate intake was lower in Group 2 (45%), with fat intake (largely derived from dairy sources) similar between groups. Glucose utilization and endogenous glucose production were determined during an oral glucose tolerance test (OGTT) with a novel double-tracer approach. The secondary aim was to determine the effect of a diet high in dairy consumption on blood lipid profiles. The investigators measured blood lipids before and after dietary intervention in each group.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women, ages 45-75 years AND
  • BMI greater than 30 kg/m2 AND
  • Two of the following conditions:

    • Plasma triglycerides > 130 mg/dl
    • HDL < 40 mg/dl in men or 50 mg/dl in women
    • elevated screening blood pressure (systolic > 140 or diastolic >90 mm Hg) or taking medication for hypertension
    • fasting plasma glucose > 100mg/dl

Exclusion Criteria:

  • Hemoglobin A1c > 7.5
  • History of malignancy in the 6 months prior to enrollment
  • History of lactose intolerance or dairy allergy
  • History of gastrointestinal bypass surgery (Lapband, etc)
  • History of a chronic inflammatory condition or disease (Lupus, HIV/AIDS, etc)
  • Subjects who do not or will not eat animal proteins
  • Subjects who cannot refrain from consuming protein or amino acid supplements during their participation in this study
  • Subjects who use insulin to control their blood sugar
  • Subjects whose physician will not allow suspension of oral diabetes medications for the duration of the study (~5 weeks)
  • Concomitant use of corticosteroids (ingestion, injection or transdermal)
  • Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02885935     History of Changes
Other Study ID Numbers: 138447
First Submitted: August 24, 2016
First Posted: September 1, 2016
Last Update Posted: September 1, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases