Gut Microbiome and Metabolic Health Study

Phase 2Not Yet RecruitingNCT07457723

RDC Clinical Pty Ltd90 enrolled

Overview

The goal of this clinical trial is to assess whether TRPTI (oleoylethanolamide) can reduce plasma imidazole propionate levels and improve insulin sensitivity and metabolic health in healthy adults aged 18 years and above with BMI 18.5-29.9 kg/m². The main question it aims to answer is does TRPTI reduce plasma imidazole propionate (a gut microbiota-derived metabolite linked to insulin resistance)? Researchers will compare TRPTI 300 mg to placebo in a parallel design to see if TRPTI reduces imidazole propionate levels and improves metabolic health markers compared to placebo. Participants will: * Take 2 capsules of their assigned study product daily for 8 consecutive weeks * Attend 3 clinic visits (at baseline, week 4 and week 8)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged 18 years and above * Generally healthy * BMI 18.5-29.9 kg/m2 * Able to provide informed consent * Agree to not participate in another clinical trial while enrolled in this trial * Agree not to change current diet and/or exercise frequency or intensity during entire study period * Stable diet and lifestyle for at least 4 weeks prior * Females using a prescribed form of birth control (e.g. oral contraceptive) Exclusion Criteria: * Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, thyroid gland dysfunction) * Known gastrointestinal disorders (IBD, IBS, celiac disease, etc.) * Use of antibiotics within 8 weeks prior to study entry * Regular use of medications that significantly affect gut microbiome (PPIs, laxatives, antacids) * Use of probiotics, prebiotics, or symbiotic within 4 weeks prior to study entry * Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years * Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse * Chronic past and/or current alcohol use (\>14 alcoholic drinks week) * Allergic to any of the ingredients in the active or placebo formula * Consistently (3 or more days per week) taken OEA within 4 weeksb prior to study entry * Known pregnant or lactating woman * Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion * Participants who have participated in any other non-RDC related clinical study during the past 1 month * History of infection in the month prior to the study

Outcomes

Primary Outcomes

Imidazole Propionate (ImP)

Plasma ImP concentration: Primary metabolite produced by histidine-metabolizing gut bacteria, strongly associated with insulin resistance and type 2 diabetes risk Change from baseline: Reduction in ImP levels indicating improved metabolic health