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

This study has been completed.
Information provided by (Responsible Party):
Mats Ryberg, Umeå University Identifier:
First received: June 4, 2008
Last updated: September 1, 2015
Last verified: September 2015

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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 ]
  • Apnea-Hypopnea Index (AHI) [ Time Frame: Sept 2008 ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: September 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Behavioral: NNR (Nordic Nutrition Recommendations)
Diet with equal amounts of fat, protein and carbohydrates
Other Name: Nordic Nutrition recommendations
Active Comparator: 2
Behavioral: MPD (Modified paleolithic diet)
A diet high in protein and fat, but low in carbohydrates
Other Name: Modified paleolithic diet


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

Inclusion Criteria:

  • Female
  • Postmenopausal
  • BMI>28

Exclusion Criteria:

  • Disease
  • Gravidity
  • Smoking
  • Prescribed medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00692536

Umeå University
Umeå, Sweden, SE-90187
Sponsors and Collaborators
Umeå University
Principal Investigator: Mats Ryberg, PhD, MD Umeå University, Umeå, Sweden
  More Information

No publications provided by Umeå University

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mats Ryberg, MD, PhD, Umeå University Identifier: NCT00692536     History of Changes
Other Study ID Numbers: Um dnr 07-034M
Study First Received: June 4, 2008
Last Updated: September 1, 2015
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
Diet intervention processed this record on October 08, 2015