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

University of Georgia (UGA)

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Other: Higher CARB Diet; Other: Higher PRO Diet; Behavioral: Sprint Interval Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01622634

EPHIT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 4 patient groups

Higher Protein Diet (PRO)

Active Comparator group

Treatment:

Other: Higher PRO Diet

Higher Carbohydrate Diet (CARB)

Active Comparator group

Treatment:

Other: Higher CARB Diet

PRO & Interval Exercise (PRO+EX)

Active Comparator group

Treatment:

Behavioral: Sprint Interval Exercise

Other: Higher PRO Diet

CARB & Interval Exercise (CARB+EX)

Active Comparator group

Treatment:

Behavioral: Sprint Interval Exercise

Other: Higher CARB Diet