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
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
Public, Scientific, Principal investigator
Shintomi HJ bldg 5F
1-12-7 Shintomi
Chuo-ku
104-0041
Japan
| 0000-0001-6067-4574 | |
| Phone | +81 (0)335525335 |
| development@innovationlabo.com |
Principal investigator
14-5 Kusunokichō, Nishi-ku
Yokohama-shi
Kanagawa-ken
Yokohama
220-0003
Japan
| Phone | +81 (0)335525335 |
|---|---|
| coordinate@medica-labs.jp |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional double-blind two-arm single-center randomized clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A 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 objectives | Fermented 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) studied | Improvement of glucose metabolism in overweight participants |
| Intervention | This 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 type | Supplement |
| Primary outcome measure(s) |
1. Weight measured using a calibrated digital weighing scale 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 |
| Completion date | 30/01/2025 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 44 |
| Total final enrolment | 44 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/10/2024 |
| Date of final enrolment | 01/11/2024 |
Locations
Countries of recruitment
- Japan
Study participating centre
Yokohama-shi
Kanagawa-ken
Yokohama
220-0003
Japan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The 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.