Clinical trial NCT00692536: Diet Composition - Metabolic Regulation and Long-term Compliance
Official title: Diet Composition - Metabolic Regulation and Long-term Compliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Postmenopausal
Diet intervention
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 70
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


Eligibility criteria: Inclusion Criteria:

* Female
* Postmenopausal
* BMI\>28

Exclusion Criteria:

* Disease
* Gravidity
* Smoking
* Prescribed medication

Primary outcomes:
measure: Liver fat
timeFrame: Sept 2008
Secondary outcomes:
measure: Body weight
timeFrame: Sept 2008
measure: Apnea-Hypopnea Index (AHI)
timeFrame: Sept 2008
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
Study officials:
affiliation: Umeå University, Umeå, Sweden
name: Mats Ryberg, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.