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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sprint Interval Exercise
Higher PRO Diet
Higher CARB Diet
Sponsored by
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring cardiovascular disease, diabetes mellitus

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • Body Composition and Metabolism Lab, Ramsey Center, University of Georgia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Higher Protein Diet (PRO)

Higher Carbohydrate Diet (CARB)

PRO & Interval Exercise (PRO+EX)

CARB & Interval Exercise (CARB+EX)

Arm Description

Outcomes

Primary Outcome Measures

Metabolic Syndrome Risk Factors
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. 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
Satiety will be assessed using questionnaires

Full Information

First Posted
June 15, 2012
Last Updated
September 24, 2015
Sponsor
University of Georgia
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1. Study Identification

Unique Protocol Identification Number
NCT01622634
Brief Title
Effect of a High-Protein Diet and/or High-Intensity Training on Metabolic Syndrome
Acronym
EPHIT
Official Title
The E-PHIT Study: Eggs, Protein, and High-Intensity Training: A Diabetes Prevention Program for Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
cardiovascular disease, diabetes mellitus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Higher Protein Diet (PRO)
Arm Type
Active Comparator
Arm Title
Higher Carbohydrate Diet (CARB)
Arm Type
Active Comparator
Arm Title
PRO & Interval Exercise (PRO+EX)
Arm Type
Active Comparator
Arm Title
CARB & Interval Exercise (CARB+EX)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Sprint Interval Exercise
Other Intervention Name(s)
High Intensity Training, Sprint Interval Cycling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Higher PRO Diet
Other Intervention Name(s)
Higher Protein Reduced Carbohydrate Diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Higher CARB Diet
Other Intervention Name(s)
Conventional Higher Carbohydrate Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Metabolic Syndrome Risk Factors
Description
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. 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.
Time Frame
Change [Baseline to 6 Weeks]
Secondary Outcome Measure Information:
Title
Satiety
Description
Satiety will be assessed using questionnaires
Time Frame
Change [Baseline to 6 weeks]

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen M. Evans, PhD
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kirk J. Cureton, PhD
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Body Composition and Metabolism Lab, Ramsey Center, University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States

12. IPD Sharing Statement

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

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