Effect of a High-Protein Diet and/or High-Intensity Training on Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: Higher PRO Diet; Other: Higher CARB Diet; Behavioral: Sprint Interval Exercise

• Registration Number: NCT01622634
• Lead Sponsor: University of Georgia

Brief Summary

The objective of this study is to determine the combined effects of a high-protein diet and high-intensity training on metabolic syndrome risk factors in women aged 30-65.

Detailed Description

High-protein diet interventions have been shown to be effective in reducing triglycerides and increasing high-density lipoprotein cholesterol concentrations. Low-volume, high-intensity cycling exercise has shown to elicit positive effects on metabolic syndrome risk factors such as triglyceride concentrations. The objective of this study was to determine the combined effects of a high-protein, reduced carbohydrate diet and high-intensity interval training on metabolic syndrome risk factors in women. The second primary aim is to investigate the effect of the macronutrient content of the post-exercise meal consumed following an acute bout of interval training on postprandial metabolism.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-06-15
• Study First Submitted QC: 2012-06-15
• Study First Posted: 2012-06-19
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

Inclusion Criteria

• Women aged 30-65 yrs of age, inclusive
• Waist circumference > 88 cm.
• Weight stable (within 2 kg) for past 6 mo
• Sedentary/Low-active (defined as <300minutes/wk light or moderate activity, with no vigorous activity in last 6 months)
• At risk for MetS [defined as having 2 of the following 4 factors: 1) hypertriglyceridemia defined as > 150 mg/mL, 2) low HDL cholesterol defined < 50 or on medication, 3) elevated blood pressure defined as > 130/>85 Hg or taking medications or 4) hyperglycemia defined as fasting blood glucose > 100 or glycated hemoglobin > 6.5 or taking medications.
• Willing to be randomized to the four treatment groups

Exclusion Criteria

• Any chronic disease/condition that would not permit exercise or dietary restriction (including egg allergy or refusal to incorporate eggs into the diet) or alter interpretation of data. Examples include, but are not limited to:

  1. cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease; 2) severe orthopedic, musculoskeletal or neuromuscular impairments that would contradict exercise; 3) sensory impairments that interfere with following directions; 4) diagnosis of dementia; 5) history of malignancy during the past 5 yr; 6) medication use that impacts primary outcomes of interest (e.g. statins); 7) weight greater than 400 pounds due to DXA weight and size limitations; 8) Uncontrolled blood pressure defined as > 160/>100 Hg.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Higher Protein Diet (PRO)	Higher PRO Diet	-
Higher Carbohydrate Diet (CARB)	Higher CARB Diet	-
PRO & Interval Exercise (PRO+EX)	Sprint Interval Exercise	-
CARB & Interval Exercise (CARB+EX)	Higher CARB Diet	-
PRO & Interval Exercise (PRO+EX)	Higher PRO Diet	-
CARB & Interval Exercise (CARB+EX)	Sprint Interval Exercise	-

Primary Outcome Measures

Name	Time	Method
Metabolic Syndrome Risk Factors	Change [Baseline to 6 Weeks]	1. Post-Prandial Lipemia (and/or metabolic responses including insulin, glucose, triglycerides and free-fatty acids) to: a) a high fat meal challenge and b) a meal challenge similar to the higher protein or carbohydrate treatment arm. After an overnight fast and baseline blood draws, participants will consume a small meal and have their blood sampled every 30 minutes for 3 hours.; 2. Biomarkers for Cardiovascular Disease and Diabetes Mellitus. Fasting blood samples for serum lipids, glucose, insulin and systemic inflammation (C-reactive protein) will be taken after an overnight fast.

Secondary Outcome Measures

Name	Time	Method
Satiety	Change [Baseline to 6 weeks]	Satiety will be assessed using questionnaires

Trial Locations

Locations (1)

Body Composition and Metabolism Lab, Ramsey Center, University of Georgia; 🇺🇸 Athens, Georgia, United States