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
  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:


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
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 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 by Umeå University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 20, 2014