NCT00692536

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

September 3, 2015

Status Verified

September 1, 2015

Enrollment Period

2.8 years

First QC Date

June 4, 2008

Last Update Submit

September 1, 2015

Conditions

Obesity

Keywords

ObesityPostmenopausalDiet intervention

Outcome Measures

Primary Outcomes (1)

  • Liver fat

    Sept 2008

Secondary Outcomes (2)

  • Body weight

    Sept 2008

  • Apnea-Hypopnea Index (AHI)

    Sept 2008

Study Arms (2)

1

ACTIVE COMPARATOR

NNR

Behavioral: NNR (Nordic Nutrition Recommendations)

2

ACTIVE COMPARATOR

MPD

Behavioral: MPD (Modified paleolithic diet)

Interventions

NNR (Nordic Nutrition Recommendations)BEHAVIORAL

Diet with equal amounts of fat, protein and carbohydrates

Also known as: Nordic Nutrition recommendations
1
MPD (Modified paleolithic diet)BEHAVIORAL

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

Also known as: Modified paleolithic diet
2

Eligibility Criteria

AgeUp to 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Postmenopausal
  • BMI\>28

You may not qualify if:

  • Disease
  • Gravidity
  • Smoking
  • Prescribed medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University

Umeå, SE-90187, Sweden

Location

Related Publications (7)

  • 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.

    PMID: 35879528DERIVED

  • 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.

    PMID: 32827219DERIVED

  • 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.

    PMID: 32428300DERIVED

  • 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.

    PMID: 28901333DERIVED

  • 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.

    PMID: 28440046DERIVED

  • 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.

    PMID: 26139105DERIVED

  • 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.

    PMID: 24739099DERIVED

MeSH Terms

Conditions

Obesity

Interventions

pyrophosphomevalonate decarboxylase

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mats Ryberg, PhD, MD

    Umeå University, Umeå, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 6, 2008

Study Start

September 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

September 3, 2015

Record last verified: 2015-09

Locations

SE(1)