Activity of Bioactive Natural Compounds as Potential Agonists of GLP1R

NCT06513715 | Active Not Recruiting

• 1 other identifier: BIOBESICOM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if natural bioactive compound jubenine works to reduce appetite and to favour weight loss. It will also learn about the safety of natural bioactive compound jubenine. The main questions it aims to answer are: Does natural bioactive compound jubenine reduce the hunger perception or increase the satiety perception, and, consequently, reduce food intake? What medical problems do participants have when taking natural bioactive compound jubenine? Researchers will compare natural bioactive compound jubenine to a placebo (a look-alike substance that contains no drug) to see if natural bioactive compound jubenine works to reduce food intake for obesity treatment. Participants will: Take natural bioactive compound jubenine or a placebo three times every day for 3 months. Visit the clinic once every 1 week for checkups and tests. Keep a diary of their symptoms and potenital adverse effects.

Conditions

Obesity; Overweight

Keywords

weight loss; prickly pear; obesity; overweight; appetite; hunger; satiety

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Percentage of weight loss from baseline weight

  First evaluation will be made after 3 months of treatment, and a second evaluation will be made 12 months later.

Study Arms (4)

CONTROL

PLACEBO COMPARATOR

The participants allocated in this arm will follow a treatment with placebo

Dietary Supplement: Control

Intervention 1

EXPERIMENTAL

The participants in this arm will receive a 150 mg dose of jubenine

Dietary Supplement: Jubanine

Intervention 2

EXPERIMENTAL

The participants in this arm will receive a 300 mg dose of jubenine

Dietary Supplement: Jubanine

Intervention 3

EXPERIMENTAL

The participants in this arm will receive a 300 mg dose of prickly pear extract

Dietary Supplement: Jubanine

Interventions

Control DIETARY_SUPPLEMENT

This intervention will be made with a placebo

CONTROL

Jubanine DIETARY_SUPPLEMENT

This intervention will be made with jubanine or prickly pear extract

Intervention 1; Intervention 2; Intervention 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI over 24.9
• no clinically relevant abnormalities and no relevant systemic disease history

You may not qualify if:

• the presence of any clinically relevant symptoms or severe disease within 4 weeks of the start of the study
• any history of hepatic dysfunction, any condition that might affect the pharmacokinetics properties of the study drug.
• diarrhoea (\>2 liquid stools per day) or constipation (3 days duration) 1 week prior to the start of the study
• history of hypersensitivity to GLP1R agonists
• evidence of hepatitis B or C, HIV positivity
• smoking (\>4 cigarettes/day)
• history of alcohol or substance abuse
• bulimia or laxative abuse

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Faculty of Nursing. Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Interventions

jubanine C

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Juan José Hernández Morante, PhD

  Universidad Católica San Antonio de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Nursing Research Coordinator

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: January 9, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available after ending the study.
• Access Criteria: Study protocol and statistical plan will be available online for all users. Informed consent form and clinical study report will be accesible under reasonable request.

Locations

ES (1)