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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Sprint Interval Exercise
* Other: Higher PRO Diet
* Other: Higher CARB Diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Higher Protein Diet (PRO)<br> | Other: Higher PRO Diet<br>* 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.<br>* Other names: Higher Protein Reduced Carbohydrate Diet;|
| Active Comparator: Higher Carbohydrate Diet (CARB)<br> | Other: Higher CARB Diet<br>* 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.<br>* Other names: Conventional Higher Carbohydrate Diet;|
| Active Comparator: PRO & Interval Exercise (PRO+EX)<br> | Behavioral: Sprint Interval Exercise<br>* 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.<br>* Other names: Sprint Interval Cycling;Other: Higher PRO Diet<br>* 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.<br>* Other names: Higher Protein Reduced Carbohydrate Diet;|
| Active Comparator: CARB & Interval Exercise (CARB+EX)<br> | Behavioral: Sprint Interval Exercise<br>* 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.<br>* Other names: Sprint Interval Cycling;Other: Higher CARB Diet<br>* 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.<br>* Other names: Conventional Higher Carbohydrate Diet;|

What is the study measuring?
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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] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, diabetes mellitus