Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/09/2005
Date assigned
09/09/2005
Last edited
18/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Angelo Tremblay

ORCID ID

Contact details

Division of Kinesiology
Room 0234
PEPS Building
Laval University
Ste-Foy
G1K 7P4
Canada
+1 418-656-7294
angelo.tremblay@kin.msp.ulaval.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MOP-44151

Study information

Scientific title

Acronym

Study hypothesis

Obesity treatment - A multi-vitamin supplement attenuates the reduction in energy metabolism-related variables and attenuates the increase in appetite following an energy deficit and a body weight loss
1. Determine the impact of a weight-reducing program on daily energy needs of obese individuals
2. Evaluate the effects of micronutrient supplementation on changes in energy expenditure and feeding behavior that occur in response to weight loss
3. Investigate the relationship between changes in energy expenditure and those in plasma thyroid hormones and organochlorines

Ethics approval

Comité d'éthique de la recherche, Université Laval, 21 August 2001

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Overweight and obese individuals.

Intervention

Experimental group: Energy restriction of approximately -700 kcal/day during 15 weeks. Daily consumption of a multi-vitamin supplement during 15 weeks.
Control group: Energy restriction of approximately -700 kcal/day during 15 weeks plus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Mmicronutrients

Primary outcome measures

Accentuated body weight and fat mass loss in multivitamin and mineral supplemented group.

Secondary outcome measures

1. Attenuation of the reduction in daily and resting energy expenditure following body weight loss in the multi-vitamin supplemented group
2. Attenuation of the decrease in fat oxidation following body weight loss in the multi-vitamin supplemented group
3. Attenuation of the increase in appetite-related variables and energy intake following energy deficit and body weight loss in the multi-vitamin supplemented group
4. Decrease in energy expenditure following body weight loss, which will be accompanied by an increase in organochlorine plasma concentration

Overall trial start date

01/11/2001

Overall trial end date

31/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Body Mass Index (BMI) between 30 kg/m^2 and 40 kg/m^2
2. Aged 23 - 47 years old, non-menopaused women
3. Weight circumference of 90
4. Stable body weight during 6 months prior to study
5. Non-smoking
6. Sedentary (less than 1 hour/week of continuous physical activity)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

80

Participant exclusion criteria

1. Abnormal blood pressure values
2. Use of medication that could potentially interfere with the study's objectives
3. Consumption of vitamin and mineral supplements 6 months prior the beginning of the study

Recruitment start date

01/11/2001

Recruitment end date

31/01/2004

Locations

Countries of recruitment

Canada

Trial participating centre

Division of Kinesiology
Ste-Foy
G1K 7P4
Canada

Sponsor information

Organisation

Laval University, Quebec (Canada)

Sponsor details

Vice rectorat a la recherche
Pavillion des science et de l’education
Cité Universitaire
C.P. 2208
Québec
G1K 7P4
Canada

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP-44151)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes