Effect of a High-Protein Diet and/or High-Intensity Training on Metabolic Syndrome
EPHIT
The E-PHIT Study: Eggs, Protein, and High-Intensity Training: A Diabetes Prevention Program for Women
1 other identifier
interventional
49
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 15, 2012
CompletedFirst Posted
Study publicly available on registry
June 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedSeptember 25, 2015
September 1, 2015
1.1 years
June 15, 2012
September 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolic Syndrome Risk Factors
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.
Change [Baseline to 6 Weeks]
Secondary Outcomes (1)
Satiety
Change [Baseline to 6 weeks]
Study Arms (4)
Higher Protein Diet (PRO)
ACTIVE COMPARATORHigher Carbohydrate Diet (CARB)
ACTIVE COMPARATORPRO & Interval Exercise (PRO+EX)
ACTIVE COMPARATORCARB & Interval Exercise (CARB+EX)
ACTIVE COMPARATORInterventions
Participants will undergo sprint interval training on a cycle ergometer 3 times weekly for 6 weeks. Each training session begins with a 5-minute active warm-up. The warm-up is followed by 4-7 bouts of 30 seconds of all-out sprints and 4 minutes of active recovery.
Participants in the PRO and PRO+EX groups will meet weekly with a diet specialist on staff to monitor their intake and compliance with the high protein diet.
Participants in the CHO and CHO+EX groups will meet weekly with a diet specialist on staff to monitor their intake and compliance with the higher carbohydrate diet.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Body Composition and Metabolism Lab, Ramsey Center, University of Georgia
Athens, Georgia, 30602, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellen M. Evans, PhD
University of Georgia
- PRINCIPAL INVESTIGATOR
Kirk J. Cureton, PhD
University of Georgia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Principal Investigator
Study Record Dates
First Submitted
June 15, 2012
First Posted
June 19, 2012
Study Start
February 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
September 25, 2015
Record last verified: 2015-09