Gut Microbiome and Metabolic Health Study
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRDC Clinical Pty Ltd
About this trial
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)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18 years and above
Generally healthy
BMI 24.9 - 34.9 kg/m2
Able to provide informed consent
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
TRPTI 300mg
Dietary supplementParticipants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg
Placebo
Other interventionParticipants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: TRPTI 300mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline to week 8Secondary outcomes
1
Gut Microbiome Composition
Gut microbiome composition and functional capacity will be assessed from stool samples using 16S rRNA gene sequencing and metagenomic sequencing. Analyses will evaluate overall microbial community structure, relative abundance of histidine-metabolising bacteria, and functional pathways related to imidazole propionate production. Measurement details: Analytical method: 16S rRNA gene sequencing and shotgun metagenomic sequencing Units: Relative abundance (%), diversity indices (unitless), and pathway abundance (relative abundance)
Time frame
Baseline to week 82
Histidine Metabolic Pathway - Histidine
Histidine: Precursor amino acid for ImP synthesis. Plasma histidine concentration will be quantified as a marker of substrate availability within the histidine metabolic pathway.
Time frame
Baseline to week 83
Histidine Metabolic Pathway - Histamine
Histamine: Alternative histidine metabolite. Plasma histamine concentration will be measured as an alternative downstream metabolite of histidine metabolism.
Time frame
Baseline to week 84
Histidine Metabolic Pathway - Urocanic acid
Urocanic acid: Intermediate metabolite in histidine degradation pathway. Plasma urocanic acid concentration (µmol/L), an intermediate metabolite in the histidine degradation pathway, will be quantified.
Time frame
Baseline to week 8Other outcomes
1
Other: Anthropometrics
Anthropometrics provide demographics information and context for metabolic outcomes (e.g., HOMA indices) and help interpret whether any biochemical changes could be partly explained by changes or differences in body mass over the 8-week period. Measures include Height, weight and BMI, hip and waist circumference.
Time frame
Screening to week 82
Exploratory: Longevity markers
Changes over 8 weeks in longevity markers - Sirtuins (SIRTs)
Time frame
Baseline to week 83
Exploratory: Methylation status
Changes over 8 weeks in methylation status
Time frame
Baseline to week 84
Exploratory: Phenotypic clock
Changes in 8 weeks in phenotypic clock
Time frame
Baseline to week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
RDC Clinical Pty Ltd
Lead sponsor
Gencor Pacific Limited, Hong Kong
Collaborator
Source ClinicalTrials.gov