Effects of OPTIMEALTH Food P 500 on gut health
| ISRCTN | ISRCTN16851495 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16851495 |
| Secondary identifying numbers | OF/GH /INNOVATION LABO 22-0421 |
- Submission date
- 28/03/2025
- Registration date
- 19/05/2025
- Last edited
- 16/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
The gut microbiota plays an important role in regulating human health and diseases. A growing body of knowledge supports the involvement of Gut microbiota dysbiosis in diseases such as diabetes, obesity, inflammatory bowel disease IBD and constipation. This study evaluates the efficacy of a postbiotic metabolite complex OPTIMEALTH Food P 500 developed by Innovation Labo, Tokyo. OPTIMEALTH Food P 500 was developed by studying the microbiota and health of healthy centenarians who have a particular microbiota profile. Innovation Labo discovered that the metabolites produced by the microbiota activate gene expression to inhibit and regulate inflammation and modulate the gut microbiome. The present study will evaluate the effect of OPTIMEALTH Food P 500 on constipation. To evaluate this, defecation frequency, stool consistency, constipation-related symptom scores, stool short-chain fatty acid (SCFA) content, gut microbiota composition and levels of oxidative biomarkers in blood will be measured.
Who can participate?
Non-smoking adult volunteers aged between 21 to 65 years old (inclusive) who have general symptoms of constipation and meet the ROME III criteria for functional constipation
What does the study involve?
Participants will be randomly assigned to a once-daily OPTIMEALTH FOOD P 500 supplement or a placebo/dummy supplement for 4 weeks.
What are the possible benefits and risks of participating?
Possible benefits are a reduction in constipation. 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?
March 2023 to February 2024
Who is funding the study?
INNOVATION LABO Sciences Co., Ltd (Japan)
Who is the main contact?
Dr Yuki Ikeda, development@innovationlabo.com (Japan)
Contact information
Scientific
Shintomi HJ bldg 5F
1-12-7 Shintomi
Tokyo
104-0041
Japan
 ORCID ID |
0000-0001-6067-4574 |
|---|---|
| Phone | +81 (0)335525335 |
| development@innovationlabo.com |
Principal Investigator
Hegenheimermattweg 167A
Allschwil
4123
Switzerland
| Phone | +81 (0)335525335 |
|---|---|
| innovation@swiss-biome.com |
Public
Shintomi HJ bldg 5F
1-12-7 Shintomi
Tokyo
104-0041
Japan
| Phone | +81 (0)335525335 |
|---|---|
| tokyo@innovationlabo.com |
Study information
| Study design | Interventional double-blind placebo-controlled single-center randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format |
| Scientific title | A prospective, randomized, double-blind, two-arm, parallel, placebo-controlled, clinical study to evaluate the efficacy of OPTIMEALTH Food P 500 supplementation on constipation symptoms, SCFAS content, and gut microbiota composition in healthy participants suffering from constipation |
| Study objectives | OPTIMEALTH Food P 500 is more efficient than a placebo in improving constipation symptoms, increasing short-chain fatty acid (SCFA) content and improving gut microbiota composition |
| Ethics approval(s) |
Approved 17/03/2023, Swiss Association of Anti-Aging Nutrition Ethics Committee (Löwenstrasse, Zürich, 8001, Switzerland; +41 (0)79811 47 83; rfaber.saan@gmail.com), ref: 2023/10-GFR105 |
| Health condition(s) or problem(s) studied | Constipation |
| Intervention | This study investigates 4 weeks of daily supplementation with OPTIMEALTH Food P 500 (300 mg/day, 150 mg x 2 capsules) or a placebo (dextrin, 300 mg/day, 150 mg x 2 capsules) 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 2n, 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 | Defecation frequency self-assessment measured using a daily chart at baseline and week 4 |
| Secondary outcome measures | The following secondary outcome measures are assessed at baseline and week 4: 1. Stool consistency by self-assessment measured using the Bristol stool chart at baseline and end of study period 2. Constipation-related symptom scores measured using a self-assessment questionnaire at baseline and end of study period 3. Stool short-chain fatty acid (SCFA) content measured using gas chromatography in fecal samples collected at baseline and end of study period. 4. Gut microbiota composition measured using quantitative PCR in fecal samples collected at baseline and end of study period 5. Antioxidant activity is tested using enzymatic and chemical assays. Blood samples were collected at baseline and end of study period and analyzed for SOD, GPx and CAT along with Total Antioxidant Capacity. 6. Inflammatory markers in saliva samples analysed using ELISA at baseline and the end of the study period |
| Overall study start date | 17/03/2023 |
| Completion date | 05/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Healthy adult male and female subjects between 21 to 65 years (inclusive) of age 2. Subjects with general symptoms of constipation and meet ROME IV criteria for functional constipation 3. Subjects with BMI between 18.5 and 29.9 kg/m² 4. Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result at the screening visit. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy 5. Subjects must be willing to give written informed consent and be willing to comply with the trial protocol 6. Subjects must have the ability to understand the risks/benefits of the protocol 7. Subjects should be available for the total duration of the study period (6 weeks) |
| Key exclusion criteria | 1. Subjects with constipation due to organic or neurological lesions 2. Subjects with a history of pathological bowel diseases like IBD or colon cancer 3. Subjects with abnormal liver or renal function 4. Subjects who have taken any prebiotic, probiotic or laxative supplements within 8 weeks of the start of the study period 5. Subjects receiving any antibiotic, anti‑inflammatory or immunosuppressive drug within the past 4 weeks 6. Subjects who have any known allergies to soy milk or any other ingredients of the test product 7. Alcoholics and drug abusers 8. Pregnant or lactating females 9. Subjects with a history of anxiety or depression or recent intake of psychotropic drugs 10. Any other condition that the Principal Investigator thinks may jeopardize the study outcome |
| Date of first enrolment | 07/11/2023 |
| Date of final enrolment | 25/12/2023 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Allschwil
4123
Switzerland
Sponsor information
Industry
Shintomi HJ bldg 5F, 1-12-7 Shintomi
Tokyo
104-0041
Japan
| Phone | +81 (0)3 35525335 |
|---|---|
| technologies@innovationlabo.com | |
| Website | https://www.innovationlabo.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| 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. Data will be available upon publication of results and for 2 years. Consent from participants was required and obtained. Data will be provided in an anonymised format. |
Editorial Notes
16/06/2025: The drug name in the public title was also changed.
20/05/2025: OPTIMEALTH FOOD P was changed to OPTIMEALTH FOOD P 500 throughout.
28/03/2025: Study's existence confirmed by the Swiss Association of Anti-Aging Nutrition Ethics Committee.
