NCT00274729

Brief Summary

The purpose of this study is to investigate the effect of three diets different in type and amount of fat in weight maintenance and prevention of life-style diseases in obese subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

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

January 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

March 25, 2010

Status Verified

January 1, 2006

First QC Date

January 10, 2006

Last Update Submit

March 24, 2010

Conditions

OverweightObesity

Keywords

Dietary interventionHigh-carbohydrate dietHigh-fat dietModerate-fat dietObesityWeight maintenanceBody compositionGlucose metabolismCardiovascular diseaseAppetite regulationEnergy expenditure

Outcome Measures

Primary Outcomes (6)

  • Changes in body weight

  • Weight loss maintenance efficacy (>5% and >10%)

  • Body composition (whole body DEXA-scanning)

  • Drop-out rate

  • Glucose metabolism (Oral Glucose Tolerance Test)

  • Endothelium function (flow-mediated vasodilatation, FMD)

Secondary Outcomes (13)

  • Changes in:

  • Blood lipids

  • Blood glucose

  • HbA1c

  • Insulin

  • +8 more secondary outcomes

Interventions

Mono Unsaturated Fatty Acids in ObesityBEHAVIORAL

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age: 16-35 years
  • Body mass index (kg/m2): 28-36

You may not qualify if:

  • Body weight fluctuations \> 3 kg over the previous 2 months
  • Smoking
  • Presence of:
  • Cardiovascular diseases, cancer tumours, kidney or lever diseases, infections or endocrinological diseases, malabsorption disorders
  • Systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg
  • Hypercholesterolemia with changes in pharmacological treatment within the last 2 months
  • Regular use of medicine other than birth pills, any psychological disorders, known or presumed abuse of alcohol, allergies to any food, special diets (eg. vegetarian) or particular dislikes
  • Pregnancy, lactating or planning pregnancy within 18 month from enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Hjorth MF, Due A, Larsen TM, Astrup A. Pretreatment Fasting Plasma Glucose Modifies Dietary Weight Loss Maintenance Success: Results from a Stratified RCT. Obesity (Silver Spring). 2017 Dec;25(12):2045-2048. doi: 10.1002/oby.22004. Epub 2017 Oct 6.

    PMID: 28985039DERIVED

  • Due A, Larsen TM, Mu H, Hermansen K, Stender S, Astrup A. Comparison of 3 ad libitum diets for weight-loss maintenance, risk of cardiovascular disease, and diabetes: a 6-mo randomized, controlled trial. Am J Clin Nutr. 2008 Nov;88(5):1232-41. doi: 10.3945/ajcn.2007.25695.

    PMID: 18996857DERIVED

  • Due A, Larsen TM, Hermansen K, Stender S, Holst JJ, Toubro S, Martinussen T, Astrup A. Comparison of the effects on insulin resistance and glucose tolerance of 6-mo high-monounsaturated-fat, low-fat, and control diets. Am J Clin Nutr. 2008 Apr;87(4):855-62. doi: 10.1093/ajcn/87.4.855.

    PMID: 18400707DERIVED

MeSH Terms

Conditions

OverweightObesityCardiovascular Diseases

Interventions

Adiposity

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Body Fat DistributionBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisBody CompositionBiochemical PhenomenaChemical PhenomenaMetabolismPhysiological Phenomena

Study Officials

  • Arne Astrup, MD DMSC

    Department of Human Nutrition, The Royal Veterinary & Agricultural University

    PRINCIPAL INVESTIGATOR

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

January 10, 2006

First Posted

January 11, 2006

Study Start

January 1, 2004

Study Completion

June 1, 2008

Last Updated

March 25, 2010

Record last verified: 2006-01