Prebiotics and probiotics in the treatment of type 2 diabetes

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 [1]

gisselgarcia2805@gmail.com [2]

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 [1]

gisselgarcia2805@gmail.com [2]

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 [1]

gisselgarcia2805@gmail.com [2]

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:

Study completion date:

09/12/2022

Date of available results:

28/02/2023

Date of first publication:

01/03/2023

Results Study

Section to complete the data related to the summarized results.

Participant flow:

Short-Chain Fructooligosaccharides Improve Gut Microbiota Composition in Patients with Type 2 Diabetes. A randomized, Open-Label, Controlled Pilot Clinical Trial. In this study, the impact of KestoMix, a syrup containing short-chain fructooligosaccharides (scFOS) mainly 1-kestose, on clinical parameters and gut microbiota composition in type 2 diabetes (T2DM) patients was investigated. The study was conducted as a randomized, open label, controlled clinical trial involving 60 participants. The control group consumed microcrystalline cellulose capsules, while the KestoMix group consumed KestoMix (7.2 g) twice a day for 12 weeks. Metabolic Shifting Probiotic in Type 2 Diabetes Mellitus Management:Randomized Clinical Trial The objective of this study is to assess the efficacy of BiotiQuest™ Sugar Shift, a probiotic formulated to transform monosaccharides and rehabilitate human gut microbiota, in stabilize HbA1c and blood glucose, improve insulin resistance, and reduce inflammation.double-blind, placebo-controlled study was carried out over 12 weeks with 64 Cubans, aged 30 to 65 with Type 2 Diabetes Mellitus diagnosed, 18 of whom being treated with insulin. Participants were randomly assigned to take either two capsules of the probiotic supplement or of placebo. Clinical measures were evaluated at 28-day intervals, included fasting and post-prandial glucose, HbA1c, lipid panel, insulin, creatinine, and serum lipopolysaccharide levels were assessed.

Baseline characteristics:

They are reflected in de PDF document attached below

Outcome measures:

They are reflected in de PDF document attached below

Adverse events:

No adverse event were reported . All participants in the study were administered either the test substance or a placebo to assess any impact on kidney function as measured by serum creatinine levels.

Summary study:

Short-Chain Fructooligosaccharides Improve Gut Microbiota Composition in Patients with Type 2 Diabetes. A randomized, Open-Label, Controlled Pilot Clinical Trial. Gissel García1, Duniesky Martínez2, Josanne Soto3, Lays Rodríguez4, Maricela Nuez5, Noraika Domínguez5, Emilio F. Buchaca4, Carlos Hernández2, Alina Sobrino2, Enrique R. Pérez2, Raúl J. Cano6* Abstract In this study, the impact of KestoMix, a syrup containing short-chain fructooligosaccharides (scFOS) mainly 1-kestose, on clinical parameters and gut microbiota composition in type 2 diabetes (T2DM) patients was investigated. The study was conducted as a randomized, open label, controlled clinical trial involving 60 participants. The control group consumed microcrystalline cellulose capsules, while the KestoMix group consumed KestoMix (7.2 g) twice a day for 12 weeks. Stool and blood samples were collected from all the subjects. The gut microbial composition in feces was analyzed for 20 subjects by next-generation sequencing of the V3–V4 region of the bacterial 16S rRNA gene. KestoMix did not significantly modify the basal clinical parameters associated with T2DM, but it significantly reduced serum LDL-c concentration at week 12. In terms of gut microbial composition, the presence of Firmicutes was higher than Bacteroidetes in both groups, but KestoMix intake resulted in a reduction in the Firmicutes/Bacteroidetes ratio. Also, a significant increase (p=0.046) in the Bacteroidetes/Proteobacteria ratio compared to the control group was observed at day 84. Furthermore, KestoMix intake significantly stimulated the increase in Bifidobacterium, as well as Blautia and Lactobacillus) (p=0.007, p=0.034 and p=0.016, respectively). While the alpha diversity of gut microbial composition was reduced after KestoMix intake, there was a change in the existing taxonomic proportions. Overall, this study highlights the positive impact of KestoMix on gut microbiota in T2DM patients. The bifidogenic effect of KestoMix may provide long-term benefits in complications associated with T2DM and other dysbiosis. Keywords: Fructooligosaccharides, prebiotic, type 2 diabetes mellitus, metagenomics sequencing, gut microbiota Metabolic Shifting Probiotic in Type 2 Diabetes Mellitus Management:Randomized Clinical Trial Gissel García1`a, Josanne Soto1b, Lays Rodríguez1c, Maricela Nuez4, Noraika Domínguez1d, Emilio F. Buchaca1c, DunieskyMartínez2, Rolando J Gómez1b, Yohanka Ávila1c, Martha R. Carlin3, Raúl J. Cano3,4* We report the results of a 12-week, double blind, placebo-controlled study designed to evaluate the symbiotic supplement BiotiQuest™ Sugar Shift (SS) in Cuban type 2 diabetes mellitus patients. The clinical parameters, including fasting and post-prandial (2h) glucose, hemoglobin A1c, a lipid panel, insulin, and creatinine were assessed using an autoanalyzer Cobas 6000, from Roche Diagnostic. Additionally, serum lipopolysaccharide levels were measured using the commercial kit ToxinSensorTM Endotoxin Detection System (GeneScript). The microbiome analysis for biodiversity was determined by 16S amplicon sequencing of the variable region V3-V4 of the 16S rRNA gene. Fasting glucose and Insulin levels decreased significantly at day 84 as compared to day 1 in the treated group compared to control group (p=0.006 and p=0.015 respectively). The principal variable, the Hb A1c, did not show significant movement in the treated group. However, decrease levels of LPS was significant in the treated group (p=0.019). These results were interpreted as the outcome of favorable microbiome favorably changes during the course of the treatment for 12 weeks. Additionally, the microbiome analysis showed significant changes in Alpha diversity in the treated group between day 1 and day 84 (p=0.0089) and also between both study groups after 84 days (0.011). Taxonomic and functional biomarkers revealed significant differences between the Day 1 and Day 84 associated to different bacteria and biomarker genes. These were primarily involved in the production of short chain fatty acids and concomitant reduction of serum LPS inflammation. In conclusion, SS, in this study, was shown to be a suitable nutritional supplement for the control of T2DM and the reduction of biomarkers associated with this dysbiosis. The positive impact in the reduction of inflammatory processes in gut suggests that this supplement can be effective in the control of inflammation in other metabolic dysbioses. Keywords: Diabetes, Probiotics, clinical trials, inflammation, insulin resistance, fasting glucose, lipopolysaccharides (LPS).

Results file:

Resumen de resultados estudio diabetes .pdf [3]

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:

2023/08/08

Next update date:

2024/08/08

Link to the spanish version:

Click here [4]