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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: Higher PRO Diet; Other: Higher CARB Diet; Behavioral: Sprint Interval Exercise

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
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30602
      • Body Composition and Metabolism Lab, Ramsey Center, University of Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: Conventional Higher Carbohydrate Diet
Active Comparator: PRO & Interval Exercise (PRO+EX)	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 Names: Higher Protein Reduced Carbohydrate Diet; 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
Active Comparator: CARB & Interval Exercise (CARB+EX)	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 Names: Conventional Higher Carbohydrate Diet; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change [Baseline to 6 Weeks]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satiety	Satiety will be assessed using questionnaires	Change [Baseline to 6 weeks]

Collaborators and Investigators

• Sponsor: University of Georgia
• Investigators: Principal Investigator: Ellen M. Evans, PhD, University of Georgia; Principal Investigator: Kirk J. Cureton, PhD, University of Georgia

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: June 15, 2012
• First Submitted That Met QC Criteria: June 15, 2012
• First Posted (Estimate): June 19, 2012

Study Record Updates

• Last Update Posted (Estimate): September 25, 2015
• Last Update Submitted That Met QC Criteria: September 24, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: cardiovascular disease; diabetes mellitus
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: EPHIT