Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/04/2018
Date assigned
18/04/2018
Last edited
18/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The purpose of this study was to examine whether lifestyle patterns mimicking those of our ancestors, such as food and movement patterns, would influence health markers for those individuals at an increased risk for disease.

Who can participate?
Individuals between the ages of 18-65 years, with an increased risk of cardiovascular and metabolic disease (i.e. Metabolic Syndrome) were recruited for this study.

What does the study involve?
Subjects consumed a Paleolithic diet for 4 weeks with sedentary activity, returned to their habitual dietary patterns and sedentary activity for 4 weeks, and then consumed the Paleolithic diet with high intensity exercise for 4 weeks.

What are the possible benefits and risks of participating?
There were no known benefits or high risks to the trial.

Where is the study run from? (what are the approximate number and names of centres taking part in this trial, if there is a lead centre, which one is it?)
This study took place at Grand Valley State University Exercise Physiology Testing Laboratory.

When is study starting and how long is it expected to run for?
Recruitment for the trial began April 20, 2016.

Who is funding the study?
No outside funding supported this trial.

Who is the main contact?
Amy Gyorkos, gyorkosa@gvsu.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Amy Gyorkos

ORCID ID

Contact details

4423 Kindschi Hall of Science
Allendale
49401
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13

Study information

Scientific title

Carbohydrate-restricted diet and HIIT exercise improves cardio-metabolic, inflammatory profiles, and cognition in metabolic syndrome: a randomized crossover trial

Acronym

Study hypothesis

Diet and exercise patterns that more closely resemble those of our evolutionary past will favorably affect inflammatory, cardio-metabolic, and cognitive profiles in individuals characterized as having metabolic syndrome.

Ethics approval

Institutional Review Board at Grand Valley State University, 20/04/2016, ref: 16-105-H

Study design

Randomized two-phase crossover trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Metabolic syndrome, according to the National Cholesterol Education Program-Adult Treatment Panel III

Intervention

The two phases of the crossover design included a carbohydrate-restricted Paleolithic-based diet with sedentary behavior (CRPD-Sed) and a carbohydrate-restricted Paleolithic-based diet with high intensity interval training (CRPD-Ex). Both phases were 4 weeks in duration and separated by a 4-week washout period during which subjects returned to baseline behaviors.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Cardiovascular and metabolic health were assessed following 4 weeks of diet or diet and exercise intervention. Blood was collected at 0, 4, 8, and 12 weeks. Assessments included lipoprotein markers (Cholestech LDX® system), adiposity (hydrostatic weighing), metabolic markers (enzyme-linked immunosorbent assay) and VO2max (peak exercise test).

Secondary outcome measures

Cognition functioning was assessed using Brain-Derived Neurotrophic Factor protein content (enzyme-linked immunosorbent assay), performance on the Stroop Test, as well as a self-reported measure of cognitive symptoms and function (Medical Outcomes Study Cognitive Functional Scale).

Overall trial start date

01/08/2015

Overall trial end date

20/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18-60 years
2. Metabolic syndrome (MetS), according to the National Cholesterol Education Program-Adult Treatment Panel III.
3. Stable weight for at least 3 months
4. Relatively sedentary (defined as engaged in exercise <30 min/day or VO2 peak <45 ml/kg/min)

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

12

Participant exclusion criteria

1. Special diets
2. Medications for chronic disease
3. Cardiovascular, metabolic, pulmonary, or osteoarticular disease

Recruitment start date

20/04/2016

Recruitment end date

20/08/2017

Locations

Countries of recruitment

United States of America

Trial participating centre

Grand Valley State University
49401
United States of America

Sponsor information

Organisation

Grand Valley State University

Sponsor details

1 Campus Drive
Allendale
49401
United States of America

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Grand Valley State University

Alternative name(s)

GVSU

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

20/08/2018

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes