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

NCT ID: NCT01622634

Last Updated: 2015-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-03-31

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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Higher Protein Diet (PRO)

Group Type ACTIVE_COMPARATOR

Higher PRO Diet

Intervention Type OTHER

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.

Higher Carbohydrate Diet (CARB)

Group Type ACTIVE_COMPARATOR

Higher CARB Diet

Intervention Type OTHER

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.

PRO & Interval Exercise (PRO+EX)

Group Type ACTIVE_COMPARATOR

Sprint Interval Exercise

Intervention Type BEHAVIORAL

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.

Higher PRO Diet

Intervention Type OTHER

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.

CARB & Interval Exercise (CARB+EX)

Group Type ACTIVE_COMPARATOR

Sprint Interval Exercise

Intervention Type BEHAVIORAL

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.

Higher CARB Diet

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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High Intensity Training Sprint Interval Cycling Higher Protein Reduced Carbohydrate Diet Conventional Higher Carbohydrate Diet

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:

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Georgia

OTHER

Sponsor Role lead

Responsible Party

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Ellen Evans

Associate Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ellen M. Evans, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Kirk J. Cureton, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Locations

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

Athens, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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EPHIT

Identifier Type: -

Identifier Source: org_study_id

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