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Completed

NCT Number: NCT00692536

Diet Composition - Metabolic Regulation and Long-term Compliance

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Umeå University

Umeå, SE-90187, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Postmenopausal
  • BMI>28

Exclusion criteria

  • Disease
  • Gravidity
  • Smoking
  • Prescribed medication

Treatment and study plan

NNR (Nordic Nutrition Recommendations)

Behavioral

Diet with equal amounts of fat, protein and carbohydrates

Other names: Nordic Nutrition recommendations

MPD (Modified paleolithic diet)

Behavioral

A diet high in protein and fat, but low in carbohydrates

Other names: Modified paleolithic diet

Primary outcomes

  1. Liver fat

    Time frame: Sept 2008

Secondary outcomes

  1. Body weight

    Time frame: Sept 2008

  2. Apnea-Hypopnea Index (AHI)

    Time frame: Sept 2008

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Acronym: KNOTA

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 6, 2008
Registry last updated
Sep 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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