Diet Composition - Metabolic Regulation and Long-term Compliance

Obesity Clinical Trial

— KNOTA  

Official title:

Diet Composition - Metabolic Regulation and Long-term Compliance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692536
• Other study ID #: Um dnr 07-034M
• Status: Completed
• Phase: N/A
• First received: June 4, 2008
• Last updated: September 1, 2015
• Start date: September 2007
• Est. completion date: June 2010

Study information

• Verified date: September 2015
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 70 Years

Eligibility

Inclusion Criteria:

• Female

• Postmenopausal

• BMI>28

Exclusion Criteria:

• Disease

• Gravidity

• Smoking

• Prescribed medication

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• NNR (Nordic Nutrition Recommendations)
Diet with equal amounts of fat, protein and carbohydrates
• MPD (Modified paleolithic diet)
A diet high in protein and fat, but low in carbohydrates

Locations

Country	Name	City	State
Sweden	Umeå University	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver fat		Sept 2008	No
Secondary	Body weight		Sept 2008	No
Secondary	Apnea-Hypopnea Index (AHI)		Sept 2008	No