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

The E-PHIT Study: Eggs, Protein, and High-Intensity Training: A Diabetes Prevention Program for Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01622634
Acronym
EPHIT
Enrollment
49
Registered
2012-06-19
Start date
2012-02-29
Completion date
2013-03-31
Last updated
2015-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

cardiovascular disease, diabetes mellitus

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.

Interventions

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.

OTHERHigher 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.

OTHERHigher 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.

Sponsors

University of Georgia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Metabolic Syndrome Risk FactorsChange [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

MeasureTime frameDescription
SatietyChange [Baseline to 6 weeks]Satiety will be assessed using questionnaires

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026