Diet Composition - Metabolic Regulation and Long-term Compliance (KNOTA)

September 1, 2015 updated by: Mats Ryberg, Umeå University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umeå, Sweden, SE-90187
        • Umea University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 68 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Postmenopausal
  • BMI>28

Exclusion Criteria:

  • Disease
  • Gravidity
  • Smoking
  • Prescribed medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
NNR
Behavioral: NNR (Nordic Nutrition Recommendations)
Diet with equal amounts of fat, protein and carbohydrates
Other Names:
  • Nordic Nutrition recommendations
Active Comparator: 2
MPD
Behavioral: MPD (Modified paleolithic diet)
A diet high in protein and fat, but low in carbohydrates
Other Names:
  • Modified paleolithic diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Liver fat
Time Frame: Sept 2008
Sept 2008

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: Sept 2008
Sept 2008
Apnea-Hypopnea Index (AHI)
Time Frame: Sept 2008
Sept 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Mats Ryberg, PhD, MD, Umea University, Umea, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

September 3, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Um dnr 07-034M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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