Effect of the prebiotic OCEAN ACTIVES® Fucoidan in promoting a healthy intestinal microbiome
Phase 1
- Conditions
- Healthy Volunteers
- Registration Number
- RPCEC00000443
- Lead Sponsor
- Hermanos Ameijeiras Clinical Surgical Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
1.Healthy Individuals 19-65 years of age without distinction of sex or skin color who give their consent
to participate in the study.
2. Not consuming probiotic formulations at the time of recruitment for the study
3. Not taking anti-inflammatory drugs
Exclusion Criteria
1. Individuals with allergies to fish and/or shellfish.
2. Individuals who suffer from the dysbiosis studied and who are ingesting some type of
probiotic formulation at the time of starting the study.
3. Individuals for whom seaweed is part of normal diet.
4. Individuals who do not consent to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fecal Microbiome Taxonomic Profile and Predicted Functional Potential of the Microbiome (It will use the bioinformatic program PICRUSt as follows: a. Inflammation Index, b. Alpha Diversity, c. Beta Diversity, d. Compositional Analysis, e. LEfSe (Linear discriminant analysis Effect Size), i. Taxonomic, ii. Functional). Measurement time: At baseline (day 0), 1 month and, 3 months<br>
- Secondary Outcome Measures
Name Time Method