Glycometabolism and lipid metabolism in obese people by metabolomics technique

ISRCTN ISRCTN76717528
DOI https://doi.org/10.1186/ISRCTN76717528
Secondary identifying numbers 30872104
Submission date
24/04/2010
Registration date
24/05/2010
Last edited
24/05/2010
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

Prof Sun Changhao
Scientific

157 Baojian Road
Nangang District
Harbin
150081
China

Phone +86 (0)451 87502801
Email sun2002changhao@yahoo.com

Study information

Study designRandomised cross-over trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA study of supplementation with multivitamins and minerals on glycometabolism and lipid metabolism in obese people by metabolomics technique: a randomised cross-over design trial
Study acronymSMUMGLMT
Study objectivesThe 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(s)Medical Ethics Committee of Public Health College, Harbin Medical University approved ethical review (001) on the 25th February 2010
Health condition(s) or problem(s) studiedDisorders of glycometabolism and lipid metabolism
Intervention1. Experimental group: 2 months multivitamin and mineral intervention
2. Control group: no intervention

After 2 months, interchange the two groups.
Intervention typeSupplement
Primary outcome measureMetabolic fingerprints
Secondary outcome measures1. 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 study start date01/02/2010
Completion date30/04/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participants120
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/02/2010
Date of final enrolment30/04/2010

Locations

Countries of recruitment

  • China

Study participating centre

157 Baojian Road
Harbin
150081
China

Sponsor information

Health College - Harbin Medical University (China)
University/education

c/o Changhao Sun
157 Baojian Road
Nangang District
Harbin
150081
China

Phone +86 0451 87502801
Email sun2002changhao@yahoo.com
Website http://yxzy.hrbmu.edu.cn/gongwei/home.asp.Public
ROR logo "ROR" https://ror.org/05jscf583

Funders

Funder type

Government

National Natural Science Foundation of China (China)
Government organisation / National government
Alternative name(s)
Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
Location
China

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