Clinical trial NCT01622634: Effect of a High-Protein Diet and/or High-Intensity Training on Metabolic Syndrome
Official title: The E-PHIT Study: Eggs, Protein, and High-Intensity Training: A Diabetes Prevention Program for Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: cardiovascular disease
diabetes mellitus
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 49
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Metabolic Syndrome Risk Factors
timeFrame: Change [Baseline to 6 Weeks]
Secondary outcomes:
measure: Satiety
timeFrame: Change [Baseline to 6 weeks]
Other outcomes:
Locations:
city: Athens
country: United States
facility: Body Composition and Metabolism Lab, Ramsey Center, University of Georgia
state: Georgia
Study officials:
affiliation: University of Georgia
name: Ellen M. Evans, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Georgia
name: Kirk J. Cureton, PhD
role: PRINCIPAL_INVESTIGATOR
References: