Diet and exercise interventions improve health markers in individuals with an increased risk of disease

ISRCTN	ISRCTN13184253
DOI	https://doi.org/10.1186/ISRCTN13184253
Secondary identifying numbers	13

Submission date: 04/04/2018
Registration date: 18/04/2018
Last edited: 18/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Amy Gyorkos
Scientific

4423 Kindschi Hall of Science
Allendale
49401
United States of America

Study information

Study design	Randomized two-phase crossover trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Carbohydrate-restricted diet and HIIT exercise improves cardio-metabolic, inflammatory profiles, and cognition in metabolic syndrome: a randomized crossover trial
Study objectives	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(s)	Institutional Review Board at Grand Valley State University, 20/04/2016, ref: 16-105-H
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/08/2015
Completion date	20/08/2017

Eligibility

Participant type(s)	Other
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Both
Target number of participants	12
Key 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)
Key exclusion criteria	1. Special diets 2. Medications for chronic disease 3. Cardiovascular, metabolic, pulmonary, or osteoarticular disease
Date of first enrolment	20/04/2016
Date of final enrolment	20/08/2017

Locations

Countries of recruitment

United States of America

Study participating centre

Grand Valley State University

49401
United States of America

Sponsor information

Grand Valley State University
University/education

1 Campus Drive
Allendale
49401
United States of America

"ROR"	https://ror.org/001m1hv61

Funders

Funder type

University/education

Grand Valley State University
Government organisation / Universities (academic only)

Alternative name(s): Grand Valley State College, Grand Valley, Grand Valley State Colleges, GVSU, GV
Location: United States of America

Results and Publications

Intention to publish date	20/08/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.