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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00692536
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : September 3, 2015
Information provided by (Responsible Party):
Mats Ryberg, Umeå University

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
Obesity Behavioral: NNR (Nordic Nutrition Recommendations) Behavioral: MPD (Modified paleolithic diet) Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : September 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Liver fat [ Time Frame: Sept 2008 ]

Secondary Outcome Measures :
  1. Body weight [ Time Frame: Sept 2008 ]
  2. Apnea-Hypopnea Index (AHI) [ Time Frame: Sept 2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Female
  • Postmenopausal
  • BMI>28

Exclusion Criteria:

  • Disease
  • Gravidity
  • Smoking
  • Prescribed medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00692536

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mats Ryberg, MD, PhD, Umeå University Identifier: NCT00692536     History of Changes
Other Study ID Numbers: Um dnr 07-034M
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: September 2015

Keywords provided by Mats Ryberg, Umeå University:
Diet intervention