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Effect of the prebiotic OCEAN ACTIVES® Fucoidan in promoting a healthy intestinal microbiome
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9 November 2024 - 10:09pm
by HHA
19 December 2025 - 2:23pm
by Gladys
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Record Verification Date
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Revision of 19 December 2025 - 2:23pm:
Effect of the prebiotic OCEAN ACTIVES® Fucoidan in promoting a healthy intestinal microbiome
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Effect of the prebiotic OCEAN ACTIVES® Fucoidan in promoting a healthy intestinal microbiome
Secondary indentifying numbers:
Not applicable
Issuing authority of the secondary identifying numbers:
Not applicable
Primary sponsor:
Hermanos Ameijeiras Clinical Surgical Hospital
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Oceanium, LTD EEuropean Marine Science Park Malin House – Suite 10 Dunbeg, Oban Scotland
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Only approved by Ethics Committees
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Gissel
Last name:
Garcia Menendez
Medical Specialty :
Biochemistry, PhD
Affiliation:
Hermanos Ameijeiras Clinical Surgical Hospital
Postal address:
San Lazaro # 701 esq. to Belascoain. Havana Center
City:
Havana
Country:
Cuba
Zip Code:
10400
Telephone:
+53-77682423
+53-52706385
Email address:
gisselgarcia2805@gmail.com
gisselgarcia@infomed.sld.cu
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Not applicable
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Complete
Date of first enrollment:
20/06/2024
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Healthy Volunteers
Intervention(s):
Group I (Experimental): Fucoidan 125 mg/capsule every 12 hours (orally) for 3 months Group II (Experimental): Fucoidan 500 mg/capsule every 12 hours (orally) for 3 months Group III (Control): Placebo Microcrystalline cellulose, 125 mg/capsule every 12 hours (orally) for 3 months
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
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
Key secondary outcomes:
1- Quality of life (SF-36 International Health Survey, which evaluates various aspects of the quality of life related to an individual's mental health). Measurement time: At baseline (Day 0), 1 month and 3 months 2- Adverse Events- AE (Presence of the AE (It doesn't seem to have any AE, Possible AE, Similar to AE, AE); Intensity of the AE (It doesn't seem to have any AE, Mild (Does not produce restrictions in daily activities), Moderate (Produces partial restriction of daily activities), Severe (inability to perform daily activities))). Measurement time: 3 months 3- Hematological variables and clinical chemistry (Laboratory values will be determined using the Cobas 6000 automatic immunochemical analyzer from the Roche Diagnóstica company. It will be determined Liver enzymes, Creatinine and Urea; Hematological parameters (Blood glucose, Leukocytes, Erythrocytes, Hemoglobin, Hematocrit, MCV, MCHC, RDW, Platelets, MPV, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils)). Measurement time: At baseline (Day 0), 1 month and 3 months 4- Inflammatory variables (C-reactive protein (normal values less than 10 mg/L), Calprotectin in feces (Values in ug/g. Normal values less than 50ug/g. A value between 50-200ug/g indicates mild intestinal inflammation)). Measurement time: At baseline (Day 0), 1 month and 3 months 5- Intestinal Transit
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
19 years
Maximum age:
65 years
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
Type of population:
Adults
Type of participant:
Healthy volunteers
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Prevention
Allocation:
Randomized controlled trial
Masking:
Double Blind
Control group:
Placebo
Study design:
Parallel
Phase:
1
Target sample size:
90
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Gissel
Last Name:
Garcia Menendez
Specialty:
Biochemistry, PhD
Affiliation:
Hermanos Ameijeiras Clinical Surgical Hospital
Postal Address:
San Lazaro # 701 esq. to Belascoain. Havana Center
City:
Havana
Country:
Cuba
Zip Code:
10400
Telephone:
+53-78761632
Email :
gisselgarcia2805@gmail.com
gisselgarcia@infomed.sld.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Gissel
Last Name:
Garcia Menendez
Specialty:
Biochemistry,PhD
Affiliation:
Hermanos Ameijeiras Clinical Surgical Hospital
Postal Address:
San Lazaro # 701 esq. to Belascoain. Havana Center
City:
Havana
Country:
Cuba
Zip Code:
10400
Telephone:
+53-78761632
Email :
gisselgarcia2805@gmail.com
gisselgarcia@infomed.sld.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
Research Ethics Committees
Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
Hermanos Ameijeiras Clinical Surgical Hospital
Status of evaluation:
Approved
Status of evaluation date of Ethic Committee:
01/04/2024
Postal address of Ethic Committee :
Calle San Lazaro # 701 esq. a Belascoain, Centro Habana, Havana, Z.C:10400, Cuba
Telephone:
+53-78761210
Email:
hha@infomed.sld.cu
About study completion
Section to complete the data related to the study completion.
Final enrolment number:
90
Study completion date:
05/11/2024
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000443
Date of Registration in Primary Registry:
31/05/2024
Record Verification Date:
2025/12/19
Next update date:
2026/12/19
Link to the spanish version:
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