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 |
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DOI | https://doi.org/10.1186/ISRCTN57519530 |
Secondary identifying numbers | 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
Scientific
Division of Kinesiology
Room 0234
PEPS Building
Laval University
Ste-Foy
G1K 7P4
Canada
Phone | +1 418-656-7294 |
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angelo.tremblay@kin.msp.ulaval.ca |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Mmicronutrients |
Primary outcome measure | 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 study start date | 01/11/2001 |
Completion date | 31/01/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 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
G1K 7P4
Canada
Sponsor information
Laval University, Quebec (Canada)
Not defined
Not defined
Vice rectorat a la recherche
Pavillion des science et de leducation
Cité Universitaire
C.P. 2208
Québec
G1K 7P4
Canada
https://ror.org/04sjchr03 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP-44151)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |