Revisions for Effect of the prebiotic OCEAN ACTIVES® Fucoidan in promoting a healthy intestinal microbiome | Registro Público Cubano de Ensayos Clínicos

--- 9 November 2024 - 10:04pm by HHA
+++ 9 November 2024 - 10:09pm by HHA
-Pending
+Complete
 - 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
 - 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
+- Intestinal Transit
-/05/31
+/11/09
-/05/31
+/11/09

Revision of 9 November 2024 - 10:09pm:

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

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

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

Date of available results:

20/01/2025

Date of first publication:

05/06/2025

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:

2024/11/09

Next update date:

2025/11/09

Link to the spanish version:

Click here

Registered Trials

Registration process

Effect of the prebiotic OCEAN ACTIVES® Fucoidan in promoting a healthy intestinal microbiome

About the RPCEC

Useful resources