Overview

This trial is active, not recruiting.

Conditions overweight, obesity
Treatments health management, general management, placebo, schsandra plus, yi rui capsule, gest aid plus: infinitus®
Sponsor Hai-Jun Wang
Start date April 2014
End date May 2015
Trial size 1452 participants
Trial identifier NCT02298426, IRB00001052-13086

Summary

This study aims to explore the effectiveness of body constitution classification based comprehensive health management intervention on obese population.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose prevention
Arm
(Experimental)
We provide large scales of weight management information included recipes according to people's constitution. Information is provide through both face to face meeting and telephones. Materials are also given to participants. Meanwhile, we use dietary supplement products of "SCHSANDRA PLUS", "YI RUI CAPSULE", "Gest Aid Plus": "INFINITUS®" to help balance the constitution of participants.
health management
We provide large scales of weight management information included recipes according to people's constitution. Information is provide through both face to face meeting and telephones. Materials are also given to participants.
schsandra plus, yi rui capsule, gest aid plus: infinitus®
We use dietary supplement products to help balance the constitution of participants. Each participant got one of the three dietary supplement products. SCHSANDRA PLUS, INFINITUS® is a health product made of Schisandra, ginseng, Ginseng, Radix and other plant materials which can help enhance the body's antioxidant capacity. YI RUI CAPSULE , INFINITUS® is a health product made of salvia, hawthorn, alisma, perilla oil microcapsules, panax powder, ginkgo biloba and other plant materials which can assist lower the blood lipid level. Gest Aid Plus, INFINITUS® is a health product made of yam, codonopsis, poria, white beans, dried tangerine peel and other plant materials which can help regulate intestinal flora.
(Experimental)
We provide general information about health. Information is provided through telephones and materials. Meanwhile, we use dietary supplement products of "SCHSANDRA PLUS", "YI RUI CAPSULE", "Gest Aid Plus": "INFINITUS®" to help balance the constitution of participants.
general management
We provide general information about health. Information is provided through telephones and materials.
schsandra plus, yi rui capsule, gest aid plus: infinitus®
We use dietary supplement products to help balance the constitution of participants. Each participant got one of the three dietary supplement products. SCHSANDRA PLUS, INFINITUS® is a health product made of Schisandra, ginseng, Ginseng, Radix and other plant materials which can help enhance the body's antioxidant capacity. YI RUI CAPSULE , INFINITUS® is a health product made of salvia, hawthorn, alisma, perilla oil microcapsules, panax powder, ginkgo biloba and other plant materials which can assist lower the blood lipid level. Gest Aid Plus, INFINITUS® is a health product made of yam, codonopsis, poria, white beans, dried tangerine peel and other plant materials which can help regulate intestinal flora.
(Experimental)
We provide large scales of weight management information included recipes according to people's constitution. Information is provide through both face to face meeting and telephones. Materials are also given to participants. Meanwhile, we use placebo to replace the dietary supplement products.
health management
We provide large scales of weight management information included recipes according to people's constitution. Information is provide through both face to face meeting and telephones. Materials are also given to participants.
placebo
We use placebo to replace the health product.
(Placebo Comparator)
We provide general information about health. Information is provided through telephones and materials. Meanwhile, we use placebo to replace the dietary supplement products.
general management
We provide general information about health. Information is provided through telephones and materials.
placebo
We use placebo to replace the health product.

Primary Outcomes

Measure
BMI
time frame: Baseline,1year

Secondary Outcomes

Measure
Body fat percentage
time frame: Baseline,1year
Fatty liver
time frame: Baseline,1year

Eligibility Criteria

Male or female participants from 20 years up to 55 years old.

Inclusion Criteria: - Social characteristics: - 20-55 year old, - had lived in a city for more than one year, - kept a watchful eye on losing weight or bodybuilding, - practitioner engaged in non- sensitive sectors. - Physiological characteristics: - met the obesity diagnostic criteria suggested by "Prevention and control Guidelines for overweight and obesity of Chinese adults in 2006". Subjects with a BMI between 24 to 28 kg/m2 were defined as overweight, while those with a BMI greater than 28kg/m2 were obese. - met the constitution classification standards of Traditional Chinese Medicine. According to the constitution questionnaire formulated on the base of the Chinese Medical Association standard "Chinese constitution classification and determination" (ZYYXH/T157-2009), the subjects were divided into phlegm-damp type, qi deficiency type and phlegm stasis block type. Exclusion Criteria: - with the following major organic disease, - secondary obesity caused by diseases, - none of phlegm-damp type, qi deficiency type or phlegm stasis block type, - women who were planning to become pregnant, pregnant or lactating.

Additional Information

Official title Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population
Principal investigator Jun Ma
Description This study aims to explore the effectiveness of body constitution classification based comprehensive health management intervention on obese population, compare the differences in effectiveness between body constitution classification based management vs usual health management, and explore the influence of different food composition on the effectiveness of body constitution classification based comprehensive health management intervention on obese population.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Peking University.