Diet Composition - Metabolic Regulation and Long-term Compliance

NCT ID: NCT00692536

Last Updated: 2015-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

NNR

Group Type ACTIVE_COMPARATOR

NNR (Nordic Nutrition Recommendations)

Intervention Type BEHAVIORAL

Diet with equal amounts of fat, protein and carbohydrates

2

MPD

Group Type ACTIVE_COMPARATOR

MPD (Modified paleolithic diet)

Intervention Type BEHAVIORAL

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

Interventions

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NNR (Nordic Nutrition Recommendations)

Diet with equal amounts of fat, protein and carbohydrates

Intervention Type BEHAVIORAL

MPD (Modified paleolithic diet)

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Nordic Nutrition recommendations Modified paleolithic diet

Eligibility Criteria

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Inclusion Criteria

* Female
* Postmenopausal
* BMI\>28

Exclusion Criteria

* Disease
* Gravidity
* Smoking
* Prescribed medication
Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Mats Ryberg

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mats Ryberg, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Umeå University, Umeå, Sweden

Locations

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Umeå University

Umeå, , Sweden

Site Status

Countries

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Sweden

References

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Franklin KA, Lindberg E, Svensson J, Larsson C, Lindahl B, Mellberg C, Sahlin C, Olsson T, Ryberg M. Effects of a palaeolithic diet on obstructive sleep apnoea occurring in females who are overweight after menopause-a randomised controlled trial. Int J Obes (Lond). 2022 Oct;46(10):1833-1839. doi: 10.1038/s41366-022-01182-4. Epub 2022 Jul 25.

Reference Type DERIVED
PMID: 35879528 (View on PubMed)

Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 Aug 21;8(8):CD011737. doi: 10.1002/14651858.CD011737.pub3.

Reference Type DERIVED
PMID: 32827219 (View on PubMed)

Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 May 19;5(5):CD011737. doi: 10.1002/14651858.CD011737.pub2.

Reference Type DERIVED
PMID: 32428300 (View on PubMed)

Manousou S, Stal M, Larsson C, Mellberg C, Lindahl B, Eggertsen R, Hulthen L, Olsson T, Ryberg M, Sandberg S, Nystrom HF. A Paleolithic-type diet results in iodine deficiency: a 2-year randomized trial in postmenopausal obese women. Eur J Clin Nutr. 2018 Jan;72(1):124-129. doi: 10.1038/ejcn.2017.134. Epub 2017 Sep 13.

Reference Type DERIVED
PMID: 28901333 (View on PubMed)

Blomquist C, Alvehus M, Buren J, Ryberg M, Larsson C, Lindahl B, Mellberg C, Soderstrom I, Chorell E, Olsson T. Attenuated Low-Grade Inflammation Following Long-Term Dietary Intervention in Postmenopausal Women with Obesity. Obesity (Silver Spring). 2017 May;25(5):892-900. doi: 10.1002/oby.21815.

Reference Type DERIVED
PMID: 28440046 (View on PubMed)

Boraxbekk CJ, Stomby A, Ryberg M, Lindahl B, Larsson C, Nyberg L, Olsson T. Diet-Induced Weight Loss Alters Functional Brain Responses during an Episodic Memory Task. Obes Facts. 2015;8(4):261-72. doi: 10.1159/000437157. Epub 2015 Jul 1.

Reference Type DERIVED
PMID: 26139105 (View on PubMed)

Hammarstrom A, Wiklund AF, Lindahl B, Larsson C, Ahlgren C. Experiences of barriers and facilitators to weight-loss in a diet intervention - a qualitative study of women in northern Sweden. BMC Womens Health. 2014 Apr 16;14:59. doi: 10.1186/1472-6874-14-59.

Reference Type DERIVED
PMID: 24739099 (View on PubMed)

Other Identifiers

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Um dnr 07-034M

Identifier Type: -

Identifier Source: org_study_id

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