We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00692536
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : September 3, 2015
Sponsor:
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
Obesity Behavioral: NNR (Nordic Nutrition Recommendations) Behavioral: MPD (Modified paleolithic diet)

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
Primary Completion Date : June 2010
Study Completion Date : June 2010

Arm Intervention/treatment
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



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

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, Learn About Clinical Studies.


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

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 ClinicalTrials.gov identifier (NCT number): 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

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
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:
Obesity
Postmenopausal
Diet intervention