Contact information
Type
Scientific
Primary contact
Prof Sun Changhao
ORCID ID
Contact details
157 Baojian Road
Nangang District
Harbin
150081
China
+86 (0)451 87502801
sun2002changhao@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
30872104
Study information
Scientific title
A study of supplementation with multivitamins and minerals on glycometabolism and lipid metabolism in obese people by metabolomics technique: a randomised cross-over design trial
Acronym
SMUMGLMT
Study hypothesis
The effects of supplementation with multivitamin and mineral on the biomarkers of glycometabolic and lipid metabolic disorders and correlated basic metabolic rate (BMR), and the effects of the metabolic fingerprints in obese people.
Ethics approval
Medical Ethics Committee of Public Health College, Harbin Medical University approved ethical review (001) on the 25th February 2010
Study design
Randomised cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Disorders of glycometabolism and lipid metabolism
Intervention
1. Experimental group: 2 months multivitamin and mineral intervention
2. Control group: no intervention
After 2 months, interchange the two groups.
Intervention type
Supplement
Phase
Not Applicable
Drug names
Multivitamin and mineral supplementation
Primary outcome measure
Metabolic fingerprints
Secondary outcome measures
1. Body height
2. Body weight
3. Waist circumference
4. Hip circumference
5. Basal metabolic rate (BMR)
6. Blood pressure
7. Body fat
8. Blood glucose
9. Blood fat
10. Endogenous creatinine clearance rate
Overall trial start date
01/02/2010
Overall trial end date
30/04/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Normal weight group: body mass index between 18.5 kg/m^2 - 24 kg/m^2
2. Obese group:
2.1. Body mass index (BMI) greater than or equal to 28 kg/m^2
2.2. Waist circumference greater than or equal to 90 cm
2.3. Stable body weight during the past 6 months (change of BMI less than 0.5 kg/m^2)
3. Aged between 18 - 25 years, male only
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
120
Participant exclusion criteria
1. Have history of liver, kidney, hypertension, genetic disease, diabetes and coronary heart disease
2. Smoker
3. Taking correlated medications which could potentially influence the purpose of this study
4. Not taking vitamin and mineral supplements in the past 6 months
Recruitment start date
01/02/2010
Recruitment end date
30/04/2010
Locations
Countries of recruitment
China
Trial participating centre
157 Baojian Road
Harbin
150081
China
Sponsor information
Organisation
Health College - Harbin Medical University (China)
Sponsor details
c/o Changhao Sun
157 Baojian Road
Nangang District
Harbin
150081
China
+86 0451 87502801
sun2002changhao@yahoo.com
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Natural Science Foundation of China (China)
Alternative name(s)
National Science Foundation of China, Natural Science Foundation of China, Chinese National Science Foundation, NSFC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
China
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
Basic results (scientific)
Publication list