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KNOTA: Diet Composition - Metabolic Regulation and Long-term Compliance

Sponsor
Umeå University (Other)
Overall Status
Completed
CT.gov ID
NCT00692536
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
33
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: NNR (Nordic Nutrition Recommendations)
  • Behavioral: MPD (Modified paleolithic diet)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Diet Composition - Metabolic Regulation and Long-term Compliance
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Liver fat [Sept 2008]

    Secondary Outcome Measures

    1. Body weight [Sept 2008]

    2. Apnea-Hypopnea Index (AHI) [Sept 2008]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Female

    • Postmenopausal

    • BMI>28

    Exclusion Criteria:

    • Disease

    • Gravidity

    • Smoking

    • Prescribed medication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Umeå University Umeå Sweden SE-90187

    Sponsors and Collaborators

    • Umeå University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mats Ryberg, MD, PhD, Umeå University
    ClinicalTrials.gov Identifier:
    NCT00692536
    Other Study ID Numbers:
    • Um dnr 07-034M
    First Posted:
    Jun 6, 2008
    Last Update Posted:
    Sep 3, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by Mats Ryberg, MD, PhD, Umeå University
    Obesity
    Postmenopausal
    Diet intervention
    Additional relevant MeSH terms:
    Obesity

    Study Results

    No Results Posted as of Sep 3, 2015