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
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

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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesObesity 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) studiedOverweight and obese individuals.
InterventionExperimental 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Mmicronutrients
Primary outcome measureAccentuated body weight and fat mass loss in multivitamin and mineral supplemented group.
Secondary outcome measures1. 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 date01/11/2001
Completion date31/01/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants80
Key inclusion criteria1. 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 criteria1. 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 enrolment01/11/2001
Date of final enrolment31/01/2004

Locations

Countries of recruitment

  • Canada

Study participating centre

Division of Kinesiology
Ste-Foy
G1K 7P4
Canada

Sponsor information

Laval University, Quebec (Canada)
Not defined

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

ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan