Unique fermented turmeric extract promotes weight loss and glucose metabolism by promoting GLP-1 production in overweight individuals

ISRCTN ISRCTN18361592
DOI https://doi.org/10.1186/ISRCTN18361592
ClinicalTrials.gov (NCT) Nil known
Clinical Trials Information System (CTIS) Nil known
Protocol serial number FTE-WL-IL
Sponsor INNOVATION LABO SCIENCES Co., Ltd
Funder INNOVATION LABO Sciences Co., Ltd
Submission date
28/10/2025
Registration date
13/11/2025
Last edited
13/11/2025
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

Background and study aims
This study was designed to evaluate the effectiveness of a unique Fermented Turmeric Extract (FTE). This extract is made using a unique fermentation process that produces over 300 beneficial compounds not found in regular turmeric supplements. Unlike standard turmeric products that mainly focus on curcumin, this fermented version provides a wider range of natural, microbe-made compounds that may help the body by supporting the connection between the gut, hormones, and metabolism. Researchers believed that FTE could help the body release hormones that promote fullness and better blood sugar control by improving the balance of gut bacteria. These changes are expected to enhance insulin sensitivity, stabilize glucose levels, control appetite, and support weight loss.

Who can participate?
Non-smoker adult subjects aged between 25 to 60 years (inclusive) old who have a BMI between 28 and 35 kg/m²

What does the study involve?
Participants will be randomly assigned to a once-daily Fermented Turmeric Extract supplement or a commercially available turmeric extract supplement for 4 weeks.

What are the possible benefits and risks of participating:
Possible benefits are a reduction in weight and the modulation of blood sugar. No risk is expected.

Where is the study run from?
INNOVATION LABO Sciences Co., Ltd (Japan)

When is the study starting and how long is it expected to run for?
June 2024 to January 2025

Who is funding the study?
INNOVATION LABO Sciences Co., Ltd (Japan)

Who is the main contact?
Dr Yuki Ikeda, development@innovationlabo.com

Contact information

Dr Yuki Ikeda
Public, Scientific, Principal investigator

Shintomi HJ bldg 5F
1-12-7 Shintomi
Chuo-ku
104-0041
Japan

ORCiD logoORCID ID 0000-0001-6067-4574
Phone +81 (0)335525335
Email development@innovationlabo.com
Dr Taro Hirata
Principal investigator

14-5 Kusunokichō, Nishi-ku
Yokohama-shi
Kanagawa-ken
Yokohama
220-0003
Japan

Phone +81 (0)335525335
Email coordinate@medica-labs.jp

Study information

Primary study designInterventional
Study designInterventional double-blind two-arm single-center randomized clinical trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA prospective, randomized, double-blind, two-arm, parallel, clinical study to evaluate the efficacy of fermented turmeric extract supplementation on weight loss and glucose metabolism in healthy overweight participants
Study objectivesFermented Turmeric Extract is more efficient than a commercially available turmeric extract in promoting weight loss and improving glucose metabolism
Ethics approval(s)

Approved 30/06/2024, Japanese Society of Anti-Aging Nutrition Ethics Review Committee (Ginza, Tokyo 6-6-1, Chuo-ku, 104-0061, Japan; +81 (0)3 3552 5277; coordinator@jaan.jp), ref: JAAN/IR 12-017

Health condition(s) or problem(s) studiedImprovement of glucose metabolism in overweight participants
InterventionThis study investigates 8 weeks of daily supplementation with Fermented Turmeric Extract (300 mg/day, one capsule) or a commercially available Turmeric Extract (300 mg/day, one capsule) taken orally at breakfast. Block randomization was used to allocate participants to each group.

Block randomization is used to divide potential patients into m blocks of size n, randomize each block such that n patients are allocated to A and n to B then choose the blocks randomly. This method ensures equal treatment allocation within each block if the complete block is used.
Intervention typeSupplement
Primary outcome measure(s)

1. Weight measured using a calibrated digital weighing scale at day 0 and day 56
2. Fat mass, lean mass, BMI measured using a bioelectrical impedance analysis at day 0 and day 56
3. Waist circumference, hip circumference, thigh circumference measured at day 0 and day 56

Key secondary outcome measure(s)

1. GLP-1 levels measured using an enzyme-linked immunosorbent assay at day 0 and day 56
2. PYY levels measured using an enzyme-linked immunosorbent assay at day 0 and day 56
3. Ghrelin leptin and adiponectin levels measured using an enzyme-linked immunosorbent assay at day 0 and day 56
4. Blood glucose measured using a hexokinase enzymatic method at day 0 and day 56
5. Insulin level measured using a chemiluminescent immunoassay at day 0 and day 56
6. Fecal microbiome composition measured using quantitative PCR at day 0 and day 56

Completion date30/01/2025

Eligibility

Participant type(s)Population
Age groupAdult
Lower age limit25 Years
Upper age limit60 Years
SexAll
Target sample size at registration44
Total final enrolment44
Key inclusion criteria1. BMI between 28 and 35 kg/m²
2. Commitment to maintaining their usual dietary habits and physical activity levels throughout the study period.
Key exclusion criteria1. Pregnancy
2. Lactation
3. History of serious medical conditions such as cancer
4. Known allergies to turmeric or any component of the test product
5. Use of medications or dietary supplements that could impact body weight or metabolic function
Date of first enrolment01/10/2024
Date of final enrolment01/11/2024

Locations

Countries of recruitment

  • Japan

Study participating centre

Medica Tokyo Laboratories
14-5 Kusunokichō, Nishi-ku
Yokohama-shi
Kanagawa-ken
Yokohama
220-0003
Japan

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr Yuki Ikeda (development@innovationlabo.com). Anonymised IPD will be available upon publication of results and for a period of 2 years. Consent from participants was required and obtained.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

03/11/2025: Study's existence confirmed by the Japanese Society of Anti-Aging Nutrition Ethics Review Committee.