The Influence of GNiib® in Obesity Management in Obese Young Individuals in Hong Kong.

Launched by CHINESE UNIVERSITY OF HONG KONG · Aug 10, 2021

Keywords

ClinConnect Summary

Study Design:

This will be a 24-week randomized double-blinded placebo-controlled study on the effect of G-NiiB®, CU Medicine Immunity Microbiome Formula, on young obese individuals who exited from a randomized controlled interventional trial with dietary intervention with low GI diet for 12-month that was conducted in 2010 (NCT no. 01278563). This study protocol complies with the Declaration of Helsinki and ICH-GCP guideline.

Subjects and Methods:

Inclusion Criteria:

1. 281 obese adolescents who participated in the randomized controlled interventional trial with low GI index diet
2. Wi...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 281 obese adolescents who participated in the randomized controlled interventional trial with low GI index diet
• • 2. Willingness to give written consent
• Exclusion Criteria:
• • 1. Subjects who are allergic to any ingredients listed in G-NiiB®, microbiome immunity formula.
• • 2. Subjects with any condition that the investigator deems as a sound reason (e.g. active gastrointestinal diseases and malignancies) for disqualification from enrollment into the study.