WPMDE1 - Whey Protein Milk-Derived Exosomes Among Healthy Subjects

NCT06742203 | Completed

• 1 other identifier: WPMDE1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 1, single-center, open-label study aims to evaluate the tolerability and usability of WPMDE1, a whey protein milk-derived exosome (EV) nutritional supplement, in healthy adults. The study will assess dose tolerability and determine the appropriate dosage for future studies targeting patients with Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD).

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

• Tolerability of adverse symptoms over the study period.

  Tolerability: Identification of dose ranges that do not cause discomfort or adverse symptoms over the study period.

  up to 30 days

Study Arms (1)

Exosomm treatment

EXPERIMENTAL

Experimental Group: WPMDE1 - Whey Protein Milk-Derived Exosomes Administered as a powder dissolved in water and taken orally twice daily in pre-measured sachets.

Dietary Supplement: Whey Protein Milk-Derived EVs

Interventions

Whey Protein Milk-Derived EVs DIETARY_SUPPLEMENT

WPMDE1 - Whey Protein Milk-Derived EVs, is a white powder obtained by filtration, concentration, and dehydrating whey solution, with the addition of sweeteners and flavorings to balance the taste. The WPMDE1 contains a known concentration of EVs (also known as milk exosomes).

Exosomm treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants who have not undergone any major surgeries or hospitalization 6 months prior to entering the study
• All genders
• Participants aged 18-60
• Participants with no underlying known health or mental conditions
• Participants who are not participating in another clinical study simultaneously or taking any other nutritional supplements or chronic drugs.
• Participants must pre-sign the informed consent form.

You may not qualify if:

• participants with chronic diseases, particularly those that are related to the GI tract
• Participants with cow milk allergy/ intolerance or history of such.
• Participants suffering from constipation or diarrhea
• Participants who use drugs or drink alcohol on a regular basis (more than one glass per week)
• Pregnant or breastfeeding women
• Participants with a BMI over 30

Sponsors & Collaborators

• Exosomm Ltd.: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Tolerability: Identification of dose ranges that do not cause discomfort or adverse symptoms over the study period.

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: October 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

IL (1)