Prebiotics and prebiotics in the treatment of type 2 diabetes

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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 BiotiQuest™ Sugar Shift and Kesto Mix dietary supplements in the treatment of type 2 diabetes mellitus (T2DM).

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Biocollective LLC, Denver Colorado, EE. UU.,

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 :

Biochemestry, Master in Virology

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital (HHA)

Postal address:

San Lazaro 701 esq. a Belascoain, Centro Habana

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78761623 ext. 1632

+53-52706385

Email address:

gisselgarcia@infomed.sld.cu

gisselgarcia2805@gmail.com

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:

25/06/2021

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:

Type 2 Diabetes Mellitus

Health condition(s) code:

Diabetes Mellitus, Type 2

Diabetes Mellitus

Glucose Metabolism Disorders

Metabolic Deseases

Nutricional and Metabolic Deseases

Endocrine System Deseases

Intervention(s):

Group 1 - BiotiQuest™ Sugar Shift Probiotic Capsules (Experimental): One capsule will be administered orally every 12 hours for 12 weeks. Each capsule contains 96 mg (18 billion CFU) of a bacterial consortium of eight strains of bacteria classified as GRAS. prebiotics inulin (50mg), and inert compounds fillers consisting of microcrystalline cellulose a, D-mannitol, and stearic acid. Group 2 - Nutriflora Prebiotic Capsules (Control): It will be administered, orally, one capsule every 12 hours, for 12 weeks. each capsule Contains 50 mg of prebiotics (Inulina) and inert componets (microcrystalline cellulose, D-mannitol, and stearic acid) . It acts as a placebo for the dose used. Group 3 - Kesto Mix Prebiotic Syrup (Experimental): It will be administered, for orally, 5ml of Kesto Mix syrup every 12 hours, for 12 weeks.

Intervention code:

Dietary Supplements

Probiotics

Prebiotics

Tablets

Placebos

Intervention keyword:

Dietary Supplements BiotiQuest™ Sugar Shift and Kesto Mix

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):

Glycosylated hemoglobin A1c (Hb-A1c) (values in %). Measurement time: Day 1 and 84.

Key secondary outcomes:

Fasting glucose (values in mmol/L obtained from samples of serum). Measurement time: Day 1, 28, 56 and 84. Postprandial glucose (2h) (values in mmol/L obtained from samples of serum). Measurement time: Day 1, 28, 56 and 84. Cholesterol (values in mmol/L obtained from serum samples). Time of measurement: Day 1 y84. Triglycerides (values in mmol/L obtained from serum samples). Time of measurement: Day 1 and 84. HDLc (values in mmol/L obtained from serum samples). Time of measurement: Day 1 and 84. LDLc (values in mmol/L obtained from serum samples). Time of measurement: Day 1 and 84. Insulin (values in mIU/mL obtained from serum samples). Time of measurement: Day 1 and 84. Creatinine (values in µmol/L obtained from serum samples). Time of measurement: Day 1 and 84. LPS (Endotoxin Units/mL obtained from serum samples). Time of measurement: Day 1 and 84. Microbiome analysis (values in mIU/mL obtained from feces). Time of measurement: Day 1 and 84.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

30 years

Maximum age:

65 years

Inclusion criteria:

1. Age from 30 to 65 years (both inclusive), of any gender or skin color 2. Patients with a clinical diagnosis of DM2 3. Able and willing to give informed written consent.

Exclusion criteria:

1. Patients with chronic kidney disease, oncoproliferative diseases and pregnant women. 2. Patients with intellectual or psychological dysfunction that does not allow the understanding and compliance with the requirements of the study, according to the criteria of the Principal Investigator.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Placebo

Study design:

Parallel

Phase:

N/A

Target sample size:

150

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, Master in Virology

Affiliation:

Hermanos Ameijeiras Surgical Clinical Hospital

Postal Address:

Calle San Lazaro 701 esq. a Belascoain, Centro Habana

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-77682423

Email :

gisselgarcia@infomed.sld.cu

gisselgarcia2805@gmail.com

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, Master in Virology

Affiliation:

Hermanos Ameijeiras Surgical Clinical Hospital

Postal Address:

Calle San Lazaro 701 esq. a Belascoain, Centro Habana

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-7768423

Email :

gisselgarcia@infomed.sld.cu

gisselgarcia2805@gmail.com

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Hermanos Ameijieras Clinical Surgery Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

22/06/2021

Postal address of Ethic Committee :

San Lázaro 701 esq. Belascoain, Centro Habana, CP 10300. Havana, Cuba

Telephone:

+53-78761000

Correo electrónico:

hha@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

85

Study completion date:

09/12/2022

Date of available results:

28/02/2023

Date of first publication:

01/03/2023

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:

RPCEC00000413

Date of Registration in Primary Registry:

06/12/2022

Record Verification Date:

2022/12/06

Next update date:

2023/12/06

Link to the spanish version:

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Ensayos Registrados

Proceso de Registro

Prebiotics and prebiotics in the treatment of type 2 diabetes

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