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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ellen Evans, University of Georgia
ClinicalTrials.gov Identifier:
NCT01622634
First received: June 15, 2012
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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 Intervention
Metabolic Syndrome
Behavioral: Sprint Interval Exercise
Other: Higher PRO Diet
Other: Higher CARB Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The E-PHIT Study: Eggs, Protein, and High-Intensity Training: A Diabetes Prevention Program for Women

Resource links provided by NLM:


Further study details as provided by University of Georgia:

Primary Outcome Measures:
  • Metabolic Syndrome Risk Factors [ Time Frame: Change [Baseline to 6 Weeks] ] [ Designated as safety issue: No ]
    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:
  • Satiety [ Time Frame: Change [Baseline to 6 weeks] ] [ Designated as safety issue: No ]
    Satiety will be assessed using questionnaires


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   30 Years to 65 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ellen Evans, Associate Professor, Principal Investigator, University of Georgia
ClinicalTrials.gov Identifier: NCT01622634     History of Changes
Other Study ID Numbers: EPHIT
Study First Received: June 15, 2012
Last Updated: October 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Georgia:
cardiovascular disease
diabetes mellitus

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

ClinicalTrials.gov processed this record on November 25, 2014