NCT00230919

Brief Summary

Overweight and obesity is increasing in most countries, including Norway, and the optimal diet for reducing weight is under discussion. The present study in overweight and moderate obese individuals compares a low glycemic load diet with a standard low-fat diet (as recommended from the National Nutrition Council) in an open, randomized trial over 12 months, with changes in weight loss and changes in cardiovascular risk markers as endpoints.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2004

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

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 3, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

July 1, 2011

Status Verified

February 1, 2004

Enrollment Period

2.2 years

First QC Date

September 30, 2005

Last Update Submit

June 30, 2011

Conditions

ObesityMetabolic Syndrome

Keywords

Obesity,weight loss,diet counselinglow-glycemic load

Outcome Measures

Primary Outcomes (1)

  • The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.

Secondary Outcomes (9)

  • Compare the consequences of the two strategies with respect to 3, 6, and 12 months development of the variables; glucose/insulin,

  • insulin sensitivity index,

  • number of metabolic syndrome factors,

  • high sensitive C-reactive protein,

  • lipids and lipoprotein B and

  • +4 more secondary outcomes

Interventions

Diet counselingBEHAVIORAL

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women age 30-65,
  • BMI in the range 28-35 kg/m2 for women and 28-40kg/m2 for men.
  • At least one of the following components of the metabolic syndrome; fasting triglycerides \> 1,7, fasting glucose 6,0-6,9, HDL-cholesterol \<1,03 (males) or \<1,29 (females), Blood pressure \>130/85 (with or without treatment), diet-treated diabetes mellitus or drug treated hypertension.
  • Stable weight range of 4 kg or less the last 12 weeks,
  • No major change in physical activity the last 12 weeks

You may not qualify if:

  • Any symptomatic cardiovascular disease
  • Diabetes requiring drug treatment
  • Currently on special diet
  • Hepatic/renal dysfunction
  • Hypothyroidism (unstable)
  • GI disorder impairing compliance with diet recommendation,
  • History of unstable psychiatric or medical disorder,
  • Need of lipid lowering drug,
  • Alcohol or drug abuse,
  • Participation in drug trial the last 30 days,
  • Use of drugs for weight reduction last 12 weeks, pregnancy or planned pregnancy,
  • Obesity of known endocrine origin, history of obesity surgery,
  • Uncontrolled hypertension (\>160/100),
  • Previous participation in \>3 weight reduction programs, or within last 12 months,
  • Not willing to be randomized,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulleval University Hospital, dep. of preventive cardiology

Oslo, Oslo County, N-0407, Norway

Location

Related Publications (2)

  • Klemsdal TO, Holme I, Nerland H, Pedersen TR, Tonstad S. Effects of a low glycemic load diet versus a low-fat diet in subjects with and without the metabolic syndrome. Nutr Metab Cardiovasc Dis. 2010 Mar;20(3):195-201. doi: 10.1016/j.numecd.2009.03.010. Epub 2009 Jun 6.

    PMID: 19502017RESULT

  • Heggen E, Klemsdal TO, Haugen F, Holme I, Tonstad S. Effect of a low-fat versus a low-gycemic-load diet on inflammatory biomarker and adipokine concentrations. Metab Syndr Relat Disord. 2012 Dec;10(6):437-42. doi: 10.1089/met.2012.0012. Epub 2012 Aug 13.

    PMID: 22889406DERIVED

MeSH Terms

Conditions

ObesityMetabolic SyndromeWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBody Weight Changes

Study Officials

  • Tor Ole Klemsdal, MD, Ph.D

    Ullevaal University Hospital, preventive medicine clinic

    PRINCIPAL INVESTIGATOR

  • Serena Tonstad, MD, Ph.D

    Ullevaal University Hospital, preventive medicine clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 3, 2005

Study Start

April 1, 2004

Primary Completion

June 1, 2006

Study Completion

November 1, 2006

Last Updated

July 1, 2011

Record last verified: 2004-02

Locations

NO(1)