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

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ClinicalTrials.gov Identifier: NCT01622634
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):
Ellen Evans, 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Behavioral: Sprint Interval Exercise Other: Higher PRO Diet Other: Higher CARB Diet Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The E-PHIT Study: Eggs, Protein, and High-Intensity Training: A Diabetes Prevention Program for Women
Study Start Date : February 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Higher Protein Diet (PRO) Other: Higher PRO Diet
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.
Other Name: Higher Protein Reduced Carbohydrate Diet

Active Comparator: Higher Carbohydrate Diet (CARB) Other: Higher CARB 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.
Other Name: Conventional Higher Carbohydrate Diet

Active Comparator: PRO & Interval Exercise (PRO+EX) Behavioral: Sprint Interval Exercise
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.
Other Names:
  • High Intensity Training
  • Sprint Interval Cycling

Other: Higher PRO Diet
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.
Other Name: Higher Protein Reduced Carbohydrate Diet

Active Comparator: CARB & Interval Exercise (CARB+EX) Behavioral: Sprint Interval Exercise
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.
Other Names:
  • High Intensity Training
  • Sprint Interval Cycling

Other: Higher CARB 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.
Other Name: Conventional Higher Carbohydrate Diet




Primary Outcome Measures :
  1. Metabolic Syndrome Risk Factors [ Time Frame: 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 :
  1. Satiety [ Time Frame: Change [Baseline to 6 weeks] ]
    Satiety will be assessed using questionnaires



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622634


Locations
United States, Georgia
Body Composition and Metabolism Lab, Ramsey Center, University of Georgia
Athens, Georgia, United States, 30602
Sponsors and Collaborators
University of Georgia
Investigators
Principal Investigator: Ellen M. Evans, PhD University of Georgia
Principal Investigator: Kirk J. Cureton, PhD University of Georgia

Responsible Party: Ellen Evans, Associate Professor, Principal Investigator, University of Georgia
ClinicalTrials.gov Identifier: NCT01622634     History of Changes
Other Study ID Numbers: EPHIT
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015

Keywords provided by Ellen Evans, University of Georgia:
cardiovascular disease
diabetes mellitus

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases