NCT00242021

Brief Summary

The objective of the study is to investigate the effect of fatty acid composition of a fat supplement:

  1. 1.acutely (after single intake) on subjective and objective measurements of hunger, satiety and wellness, on energy intake, and postprandial hormonal changes;
  2. 2.in the long-term (after one week) on (regulators of) fat tissue metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2005

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

December 16, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

October 18, 2005

Last Update Submit

December 13, 2022

Conditions

Obesity

Keywords

Satiety, ad libitum food intake, fatty acids, hormones

Outcome Measures

Primary Outcomes (1)

  • Subjective and objective measurements of hunger, satiety and wellness, on energy intake, and postprandial hormonal changes

Secondary Outcomes (1)

  • After one week supplementation the effect on (regulators of) fat tissue metabolism will be examined.

Interventions

Fatty acid composition of a margarine (spread)BEHAVIORAL

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy as assessed by the health and lifestyle questionnaire, physical examination and results of the pre-study laboratory tests;
  • Males aged between 18 - 60 years at Day 01 of the study;
  • Normal weight subjects and overweight/obese subjects, Body Mass Index (BMI) will be at least two units different between the heaviest normal weight and the lightest overweight subject, the largest contrast between groups will be aimed at, e.g normal weight BMI between 18 and 25 kg/m2 and overweight/obese BMI between 27.5-35 kg/m2;
  • Regular Dutch eating habits as assessed by P6468 F02 and used to breakfast consumption;
  • Non restrained eater, defined as a score of \< 2.5 in lean and \<3.25 in obese men on the Dutch Eating Behaviour Questionnaire;
  • Appropriate veins for blood sampling/cannula insertion according to TNO;
  • Voluntary participation;
  • Having given written informed consent;
  • Willing to comply with the study procedures;
  • Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years;
  • Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.

You may not qualify if:

  • Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study;
  • Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances;
  • Having a history of medical or surgical events that may significantly affect the study outcome, including any psychiatric history, and metabolic or endocrine disease, or any gastro-intestinal disorder or hypertension;
  • Use of medication that may influence appetite, and/or sensory functioning within 14 days before day 01, except paracetamol;
  • Allergic reaction to chlorhexidine and/or lidocaine (anaesthetic solution);
  • Having a history of or current alcohol consumption of more than 28 units/week;
  • Reported unexplained weight loss or gain of \> 2 kg in the month prior to the pre-study screening;
  • Mental or physical status that is incompatible with the proper conduct of the study;
  • Reported chronic and/or excessive mental or physical strain;
  • Reported slimming or medically prescribed diet;
  • Reported vegan, vegetarian or macrobiotic;
  • Use food supplement(s) and not willing to stop intake after the medical screening;
  • Smoking;
  • Claustrophobia;
  • Practicing heavy physical exercise \> 5 hours/week;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TNO Quality of Life

Zeist, Utrecht, 3704 HE, Netherlands

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Wilrike Pasman, PhD

    TNO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2005

First Posted

October 19, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

December 16, 2022

Record last verified: 2022-12

Locations

NL(1)