Diet Composition - Metabolic Regulation and Long-term Com... | NCT00692536

Studies
Diet Composition - Metabolic Regulation and Long-term Compliance

NCT00692536

Sponsor

Umeå University

Status

Completed

Last Update Posted

Sep 3, 2015Estimated

Enrollment

70Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

NNR (Nordic Nutrition Recommendations)
MPD (Modified paleolithic diet)

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jun 4, 2008

First Submission Date that Met QC Criteria

Jun 5, 2008

First Posted Date

Jun 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2015

Last Update Posted Date

Sep 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	NNR	Behavioral: NNR (Nordic Nutrition Recommendations)
2	Active Comparator	MPD	Behavioral: MPD (Modified paleolithic diet)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NNR (Nordic Nutrition Recommendations)	Behavioral	Diet with equal amounts of fat, protein and carbohydrates	1

Measure	Description	Time Frame
Liver fat		Sept 2008

Measure	Description	Time Frame
Body weight		Sept 2008
Apnea-Hypopnea Index (AHI)		Sept 2008

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
Postmenopausal
BMI>28

Exclusion Criteria:

Disease
Gravidity
Smoking
Prescribed medication

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mats Ryberg, PhD, MD	Umeå University, Umeå, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Umeå University		Umeå		SE-90187	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35879528	Derived	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.
32827219

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases