Dairy Macronutrient Effects on the Metabolic Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: Recommended protein intake; Other: Elevated protein intake

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Arkansas
• Collaborators: Dairy Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (ESTIMATE): September 1, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 1, 2016
• Last Update Submitted That Met QC Criteria: August 26, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 138447