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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mats Ryberg, Umeå University
ClinicalTrials.gov Identifier:
NCT00692536
First received: June 4, 2008
Last updated: January 15, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Obesity
 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

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

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 ]

Estimated Enrollment: 72
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
NNR
 Behavioral: NNR (Nordic Nutrition Recommendations)
Diet with equal amounts of fat, protein and carbohydrates
Other Name: Nordic Nutrition recommendations
Active Comparator: 2
MPD
 Behavioral: MPD (Modified paleolithic diet)
A diet high in protein and fat, but low in carbohydrates
Other Name: Modified paleolithic diet

  Eligibility

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

Inclusion Criteria:

  • Female
  • Postmenopausal
  • BMI>28

Exclusion Criteria:

  • Disease
  • Gravidity
  • Smoking
  • Prescribed medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692536

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

No publications provided

Responsible Party: Mats Ryberg, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT00692536     History of Changes
Other Study ID Numbers: Um dnr 07-034M
Study First Received: June 4, 2008
Last Updated: January 15, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
Obesity
Postmenopausal
Diet intervention

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013