Diet Composition - Metabolic Regulation and Long-Term Compliance - Full Text View

Sponsored by:	Umeå University
Information provided by:	Umeå University
ClinicalTrials.gov Identifier:	NCT00692536

Purpose

This study will compare a high-protein/low-carbohydrate diet (modified paleolithic diet, MPD) with a diet high in slow carbohydrates (Nordic Nutrition Recommendations, NNR). The diets will be compared with respect effects on weight reduction, metabolic regulation, and long-term compliance to the diet regimes. Seventy-two postmenopausal overweight healthy women have been recruited and will be followed for two years.

The following variables will be studied:

Anthropometry
DEXA
OGTT
Liver fat content measured with 1H-MRS
Hepatic 11β-HSD1 activity, measured with cortisone/cortisol conversion test

Condition	Intervention
Obesity	Behavioral: NNR (Nordic Nutrition Recommendations) Behavioral: MPD (Modified paleolithic diet)

MedlinePlus related topics: Obesity Obesity in Children

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	Diet Composition - Metabolic Regulation and Long-Term Compliance

Further study details as provided by Umeå University:

Primary Outcome Measures:

Liver fat [ Time Frame: Sept 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body weight [ Time Frame: Sept 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	September 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator NNR	Behavioral: NNR (Nordic Nutrition Recommendations) Diet with equal amounts of fat, protein and carbohydrates
2: Active Comparator MPD	Behavioral: MPD (Modified paleolithic diet) A diet high in protein and fat, but low in carbohydrates

Eligibility

Ages Eligible for Study:	up to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Female
Postmenopausal
BMI>28

Exclusion Criteria:

Disease
Gravidity
Smoking
Prescribed medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692536

Locations

Sweden
Umeå University	Recruiting
Umeå, Sweden, SE-90187
Contact: Mats Ryberg, PhD, MD 46-90-785-2586 mats.ryberg@medicin.umu.se
Principal Investigator: Mats Ryberg, PhD, MD

Sponsors and Collaborators

Umeå University

Investigators

Principal Investigator:

Mats Ryberg, PhD, MD

Umeå University, Umeå, Sweden

More Information

Responsible Party:	Umeå University ( Mats Ryberg )
Study ID Numbers:	Um dnr 07-034M
Study First Received:	June 4, 2008
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00692536
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:

Obesity
Postmenopausal
Diet intervention

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 16, 2009