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

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:

MedlinePlus related topics: Diabetes Exercise and Physical Fitness Metabolic Syndrome

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622634

Contacts

Contact: Rachelle M Acitelli, M.S.	704-488-7586	rach1@uga.edu
Contact: Eric C Freese, M.S.	309-360-8155	efreese2@uga.edu

Locations

United States, Georgia
Body Composition and Metabolism Lab, Ramsey Center, University of Georgia	Recruiting
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:	January 22, 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
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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