Effects of the Adiponexin formulation on the composition of the intestinal microbiome and weight regulation in individuals with a Body Mass Index greater than or equal to 25

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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:

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not appplicable

Source(s) of monetary or material support:

Realize Therapeutics, Corp 37 Sherwood Terrace, Suite 110 Lake Bluff, IL 60044 USA

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 :

Bachelor in Biochemestry, PhD in health Science

Affiliation:

“Hermanos Ameijeiras” Surgical Clinical Hospital

Postal address:

San Lazaro # 701 esq. to Belascoain. Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78765154

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:

Pending

Date of first enrollment:

11/06/2025

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 ADIPONEXIN (Experimental): 2 capsules of ADIPONEXIN will be administered every 12 hours, by oral route, for 90 days with meals containing oil or fats (4 capsules in total). The capsule is a probiotic formulation that combines the action of the probiotic bacteria Lactobacillus reuteri with marine collagen peptides, hyaluronic acid, and the carotenoid astaxanthin Group II ReuteriBiotic (Experimental): Two ReuteriBiotic capsules will be administered every 12 hours, by oral route, for 90 days with meals containing oil or fat (4 capsules total). The capsule is a probiotic formulation that combines the probiotic bacteria L. reuterii with the prebiotic fructooligosaccharides and magnesium stearate as an excipient Group III Placebo (Control): Two microcrystalline cellulose capsules will be administered every 12 hours, by oral route, for 90 days with meals containing oil or fat (4 capsules total)

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):

Bioimpedance Measurements (Using the TANITA TANITARD-545 InnerScan PRO Segmental instrument will be measured the Subcutaneous fat vs. abdominal visceral fat, Body Mass Index (BMI), Waist circumference and Lean muscle mass). Mesurement time: At baseline, 45 days and, 90 days

Key secondary outcomes:

1. Clinical chemistry parameters (A Cobas 600 modular immunoassay autoanalyzer (Roche Diagnostics) will be used. The analysis will be performed on serum samples in Fasting glucose (mmol/L), Creatinine (umol/L), Cholesterol (mmol/L), Triglycerides (mmol/L), C-Reactive Protein-hs-CRP-(mg/L), IL-6 (pg/mL), Insulin (U/ml), TSH (mIU/L), Hb A1C(%), Testosterone (nmol/L), Estradiol F (pg/ML)). Measurement time: At baseline and, 90 days 2. Leptin (It will be determined by an ELISA test Human Leptin ELISA Kit (abcam ab108879)). Measurement time: At baseline and, 90 days 3. Adiponectin (It will be determined using the Human Adiponectin ELISA Kit (abcam ab314604)). Measurement time: At baseline and, 90 days 4. Oxytocin (It will be determined using the Oxytocin ELISA Kit (abcamab133050)). Measurement time: At baseline and, 90 days 5. Serum LPS levels (It will be determined using the ELISA test using the commercial ToxinSensorTM Endotoxin Detection System Version 11242021 kit). Measurement time: At baseline and, 90 days 6. Fecal Calprotectin levels (It will be determined using the fCAL test, 200T, cobas c 501/502, PCh 200 tests). Measurement time: At baseline and, 90 days 7. Hemodynamic parameters (Heart rate (beats per minute), Blood pressure (mmHg)). Measurement time: At baseline and, 90 days 8. Bacterial composition of the specific fecal microbiome (It will be determined by sequence studies of the 16S ribosome subunit (16S rRNA V3-V4) in stool samples. Taxonomic Profile and compositional analysis will be used. The taxonomic profile analysis will be performed using PICRUSt to determine the Inflammation Index, Alpha Diversity and Beta Diversity. The compositional analysis will be performed using the prediction analysis of functional markers (orthologous genes) from the study of the microbiome using LEfSe (Linear discriminant analysis Effect Size)). Measurement time: At baseline and, 90 days 9. Quality of Life (SF-36 Health Survey in Spanish). Measurement time: At baseline and, 90 days 10. Adverse events and its intensity (It will be measured by considering the presence of the adverse effect under four categories (No apparent adverse effect, Possible adverse effect, Similar to an adverse effect, Adverse effect) and its intensity classified into three categories (Mild, Moderate, Severe)). Measurement time: During the study, up to 90 days

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. A healthy adult between 19 and 75 years old. 2. Have a Body Mass Index (BMI) equal to or greater than 25. 3. Have a waist circumference equal to or greater than 37 inches for men and 31.5 inches for women. 4. Not be undergoing weight-loss treatments, such as medications, diets, exercise, bariatric surgery, or GLP-1 analogues

Exclusion criteria:

1. Inability to provide informed consent. 2. Changes in diet or exercise during the study. 3. Consumption of functional foods enriched with nutritional supplements or probiotics in the six months prior to the study. 4. Shellfish allergy. 5. Use of antibiotics in the 15 days prior to the study or probiotic supplements during the study. 6. Presence of kidney failure, cardiovascular disease, uncontrolled hypertension, diabetes, smoking, or any precluding medical condition. 7. History of bariatric surgery or weight loss greater than 3 kg in the past two months. 8. Excessive alcohol consumption, according to the criteria established by DSM-5 or ICD-10

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:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

1

Target sample size:

75

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:

Bachelor in Biochemestry, PhD in health Science

Affiliation:

"Hermanos Ameijeiras" Surgical Clinical Hospital

Postal Address:

San Lazaro # 701 esq. to Belascoain. Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78765154

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:

Bachelor in Biochemestry, PhD in health Science

Affiliation:

"Hermanos Ameijeiras" Surgical Clinical Hospital

Postal Address:

San Lazaro # 701 esq. to Belascoain. Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78765154

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” Surgical Clinical Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

09/05/2025

Postal address of Ethic Committee :

San Lazaro # 701 esq. a Belascoain, Centro Habana, ZC:10400, Havana, Cuba

Telephone:

+53-52833178

Email:

jorgeluishernandezc astro52@gmail.com

About study completion

Section to complete the data related to the study completion.

Study completion date:

16/11/2025

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:

RPCEC00000459

Date of Registration in Primary Registry:

10/06/2025

Record Verification Date:

2025/06/10

Next update date:

2026/06/10

Link to the spanish version:

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Effects of the Adiponexin formulation on the composition of the intestinal microbiome and weight regulation in individuals with a Body Mass Index greater than or equal to 25

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