Flavinergy (extract of Black-Thai Ginger) on metabolic health of overweight adults

Phase 3

Recruiting

• Conditions: Overweight adults with BMI between 25 to 29.99 kg/m2.

• Registration Number: CTRI/2023/09/058149
• Lead Sponsor: Sam Sabinsa Group Limited

Brief Summary

The study involves 80 subjects randomized in two arms and will receive 90 days of treatment and telephonic follow-up after 7 days following the last visit. Participant will be randomized to receive either test product (Flavinergy- extract of Black- Thai Ginger)- 150mg or placebo (Microcrystalline cellulose) twice a day. Specific biomarkers like lipid profile, fasting blood sugar will be measure along with CT scan to measure the Sub-cutaneous Fat Area, Visceral Fat Area and Total Fat Area during the study period. The final statistical analysis and study report will be complied at the end of the study period.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-10-11
• Study Start: 2023-11-10

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Participants should be willing to give signed written informed consent.
• Participants should be willing to comply with the requirements of the trial/study.
• Male and Female participants aged between 25-55 years.
• Subjects whose BMI lie between 25 to 29.99 kg/m2.
• Subjects who meet any of the two criteria to be included in the study: a) Triglyceride more than 160mg/dl b) HDL Cholesterol less than 50 mg/dl in women and less than 40 mg/dl in men c) LDL Cholesterol more than 120 mg/dl d) Serum Total Cholesterol more than 200 mg/dl 6) Blood Pressure more than 130/90 mmHg without medication.
• 7. Fasting Blood Glucose more than 120 mg/dl without medication.
• 8. Ability to swallow and retain oral medications as per the protocol.

Exclusion Criteria

• Subjects who are taking any anti-obesity medication or weight reduction treatments including the herbal preparations.
• Subjects with abnormal thyroid profile.
• History of surgical procedures for weight loss.
• Use of supplements, special diet or functional foods affecting carbohydrate and lipid metabolism during the study period.
• History of chronic smoking and alcoholism.
• Pregnant, lactating women and those not willing to follow a reliable and effective contraceptive measure during the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in Visceral fat area.	1. Change in Visceral fat area from day-1 to day-90. | 2. Change in lipid profile from screening to day-90.
2. Change in lipid profile	1. Change in Visceral fat area from day-1 to day-90. | 2. Change in lipid profile from screening to day-90.

Secondary Outcome Measures

Name	Time	Method
1. Change in Body weight & BMI.	2. Mean change in Anthropometric measurement

Trial Locations

Locations (2)

Santosh Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Vagus Super Speciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Santosh Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Santosh Saklecha

Principal investigator

09845306703

ssaklecha@gmail.com