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
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