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Dairy Macronutrient Effects on the Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Recommended protein intake

Elevated protein intake

About this trial

This is an interventional basic science trial for Metabolic Syndrome

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Recommended protein intake

Elevated protein intake

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in rate of glucose disappearance

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02885935

First Posted

August 24, 2016

Last Updated

August 26, 2016

Sponsor

University of Arkansas

Collaborators

Dairy Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02885935

Brief Title

Dairy Macronutrient Effects on the Metabolic Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Arkansas

Collaborators

Dairy Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Recommended protein intake

Arm Type

Experimental

Arm Description

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

Arm Title

Elevated protein intake

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Recommended protein intake

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Elevated protein intake

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in rate of glucose disappearance

Description

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

Time Frame

Change from baseline and after 4weeks of dietary intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Citations:

PubMed Identifier

28713581

Citation

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.

Results Reference

derived

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Dairy Macronutrient Effects on the Metabolic Syndrome

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