Efficacy of OPTIMEALTH FOOD on Gut health
| ISRCTN | ISRCTN16659746 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16659746 |
- Submission date
- 15/07/2024
- Registration date
- 05/08/2024
- Last edited
- 26/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English Summary
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 developed by Innovation Labo, Tokyo. OPTIMEALTH® FOOD P 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 on constipation. To evaluate this, parameters such as changes in defecation frequency, stool consistency, constipation-related symptom scores, changes in stool short-chain fatty acid (SCFA) content, gut microbiota composition and changes in levels of oxidative biomarkers in blood will be evaluated.
Who can participate?
Non-smoker adult subjects aged between 21 to 65 years old (inclusive) who have general symptoms of constipation and meet ROME III criteria for functional constipation
What does the study involve?
Participants will be randomly assigned to a once-daily OPTIMEALTH FOOD P 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?
January 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 335525335 |
| development@innovationlabo.com |
Principal Investigator
14-5 Kusunokichō, Nishi-ku
Yokohama-shi, Kanagawa-ken
Yokohama
220-0003
Japan
| Phone | +81 335525335 |
|---|---|
| coordinate@medica-labs.jp |
Public
Shintomi HJ bldg 5F
1-12-7 Shintomi
Tokyo
104-0041
Japan
| Phone | +81 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 | No participant information sheet available |
| Scientific title | A prospective, randomized, double-blind, two-arm, parallel, placebo-controlled, clinical study to evaluate the efficacy of OPTIMEALTH® FOOD P supplementation on constipation symptoms, SCFAS content, and gut microbiota composition in healthy participants suffering from constipation |
| Study hypothesis | OPTIMEALTH FOOD P is more efficient than an placebo in improving constipation symptoms, increasing SCFAs content and improving gut microbiota composition |
| Ethics approval(s) |
1. Approved 10/10/2023, Japanese Society of Anti-Aging Nutrition (Ginza, Chuo-ku, Tokyo, 104-0061, Japan; +81 3 3552 5277; coordinator@jaan.jp), ref: ILOS24614-P782 2. Approved 17/10/2024, Swiss Association of Anti-aging Nutrition (Löwenstrasse 11, Zürich, 8001, Switzerland; +41 79 811 47 83; rfaber.saan@gmail.com), ref: 2023/10-GFR105 |
| Condition | Improvement of constipation symptoms |
| Intervention | This study investigates 4 weeks of daily supplementation with Optimealth Food (300 mg/day, 150mg x 2 capsules) or a placebo (dextrin, 300 mg/day, 150mg 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 2. Constipation-related symptom scores measured using a self-assessment questionnaire 3. Stool short-chain fatty acid (SCFA) content measured using gas chromatography 4. Gut microbiota composition measured using quantitative PCR 5. Oxidative biomarker levels in blood measured using a ferric reducing antioxidant power (FRAP) assay |
| Overall study start date | 07/01/2023 |
| Overall study end 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 |
| Participant inclusion criteria | 1. Healthy adult subjects between 21 and 65 years (inclusive) of age 2. General symptoms of constipation and meet ROME III criteria for functional constipation 3. 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. Willing to give written informed consent and be willing to comply with trial protocol 6. The ability to understand the risks/benefits of the protocol 7. Available for the duration of the study period (6 weeks) |
| Participant exclusion criteria | 1. Constipation due to organic or neurological lesions 2. A history of pathological bowel diseases like IBD or colon cancer 3. Abnormal liver or renal function 4. Taken any prebiotic, probiotic or laxative supplements within 8 weeks from the start of the study period 5. Receiving any antibiotic, anti‑inflammatory or immunosuppressive drug within the past 4 weeks 6. Known allergies to soy milk or any other test product ingredients 7. Alcoholics and or drug abusers 8. Pregnant or lactating females 9. A history of anxiety or depression or recent intake of psychotropic drugs 10. Any other condition which the Principal Investigator thinks may jeopardize the study outcome |
| Recruitment start date | 07/11/2023 |
| Recruitment end date | 25/12/2023 |
Locations
Countries of recruitment
- Japan
- Switzerland
Study participating centres
Yokohama-shi
Kanagawa-ken
Yokohama
220-0003
Japan
Allschwil
4123
Switzerland
Sponsor information
Industry
Shintomi HJ bldg 5F, 1-12-7 Shintomi
Tokyo
104-0041 Chuo-ku
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 | 31/10/2024 |
|---|---|
| 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. Anonymised IPD will be available upon publication of results and for a period of 2 years. Consent from participants was required and obtained. |
Editorial Notes
26/02/2025: The following changes were made to the trial record:
1. The ethics approval (2) was added.
2. The country of recruitment Switzerland was added.
3. The study participating centre Swiss Biome Institute was added.
16/07/2024: Study's existence confirmed by the Ethics Review Committee (Human Research) of the Japanese Society of Anti-Aging Nutrition.
