Diet Composition - Metabolic Regulation and Long-term Compliance

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: MPD (Modified paleolithic diet); Behavioral: NNR (Nordic Nutrition Recommendations)

• Registration Number: NCT00692536
• Lead Sponsor: Umeå University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Female
• Postmenopausal
• BMI>28

Exclusion Criteria

• Disease
• Gravidity
• Smoking
• Prescribed medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	MPD (Modified paleolithic diet)	MPD
1	NNR (Nordic Nutrition Recommendations)	NNR

Primary Outcome Measures

Name	Time	Method
Liver fat	Sept 2008

Secondary Outcome Measures

Name	Time	Method
Body weight	Sept 2008
Apnea-Hypopnea Index (AHI)	Sept 2008

Trial Locations

Locations (1)

Umeå University; 🇸🇪 Umeå, Sweden