Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/04/2010
Date assigned
24/05/2010
Last edited
24/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://yxzy.hrbmu.edu.cn/gongwei/home.asp.Public

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, NSFC

Funding Body Type

government organisation

Funding Body Subtype

Federal/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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes