Treatment of obesity: effects of micronutrient supplementations and variations of plasma organochlorine concentration on daily energy expenditure and feeding behaviour in obese individuals

ISRCTN	ISRCTN57519530
DOI	https://doi.org/10.1186/ISRCTN57519530
Protocol serial number	MOP-44151
Sponsor	Laval University, Quebec (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP-44151)

Submission date: 09/09/2005
Registration date: 09/09/2005
Last edited: 18/04/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Angelo Tremblay
Scientific

Division of Kinesiology
Room 0234
PEPS Building
Laval University
Ste-Foy
G1K 7P4
Canada

Phone	+1 418-656-7294
Email	angelo.tremblay@kin.msp.ulaval.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Comité d'éthique de la recherche, Université Laval, 21 August 2001
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Mmicronutrients
Primary outcome measure(s)	Accentuated body weight and fat mass loss in multivitamin and mineral supplemented group.
Key secondary outcome measure(s)	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
Completion date	31/01/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	80
Key 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)
Key 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
Date of first enrolment	01/11/2001
Date of final enrolment	31/01/2004

Locations

Countries of recruitment

Canada

Study participating centre

Division of Kinesiology

Ste-Foy
G1K 7P4
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan