Dairy Macronutrient Effects on the Metabolic Syndrome

NCT02885935 | Completed

• 1 other identifier: 138447
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Changes in rate of glucose disappearance

  Rate of glucose disappearance from plasma to body tissues is a measure of whole body insulin sensitivity

  Change from baseline and after 4weeks of dietary intervention

Study Arms (2)

Recommended protein intake

EXPERIMENTAL

Subjects consumed diets with a macronutrient distribution of 10% protein, 55% carbohydrates, and 35% fat for 4 weeks.

Other: Recommended protein intake

Elevated protein intake

EXPERIMENTAL

Subjects consumed diets with a macronutrient distribution of 20% protein, 45% carbohydrates and 35% fat for 4 weeks.

Other: Elevated protein intake

Interventions

Recommended protein intake OTHER

Recommended protein intake diet contained 10% protein, 55% carbohydrate,and 35 % fat.

Recommended protein intake

Elevated protein intake OTHER

Recommended protein intake diet contained 20% protein, 45% carbohydrate,and 35 % fat.

Elevated protein intake

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead
• Dairy Research Institute: collaborator

Related Publications (1)

• Kim IY, Schutzler SE, Azhar G, Wolfe RR, Ferrando AA, Coker RH. Short term elevation in dietary protein intake does not worsen insulin resistance or lipids in older adults with metabolic syndrome: a randomized-controlled trial. BMC Nutr. 2017;3:33. doi: 10.1186/s40795-017-0152-4. Epub 2017 Apr 17.

  PMID: 28713581 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

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

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 1, 2016
• Study Start: April 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 1, 2016

Record last verified: 2016-08