Health TrialsbyHealthPanel

TRPTI Metabolic and GLP-1 Pharmacodynamic Study

ConditionOverweight , Obesity
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age30+
SponsorRDC Clinical Pty Ltd

About this trial

The goal of this clinical trial is to assess whether TRPTI™ supplementation affects GLP-1 and related metabolic markers in generally healthy adults who are overweight or obese (BMI 25.0-34.9 kg/m², aged 30 years and older).

Researchers will compare TRPTI™ 150 mg to a matching placebo capsule to see if TRPTI™ produces a meaningful difference in GLP-1 response and associated metabolic and appetite-related markers over 8 hours.

Participants will attend two 9-hour clinic visits (crossover design, with a minimum 6-day washout between visits).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 30 years and older

Generally healthy

BMI 25.0-34.9 kg/m²

Able to provide informed consent

Disqualifiers

Have a serious illness e.g., neurological disorders such as MS, kidney disease, liver disease or heart conditions

History of any glucose or insulin regulation problem, including diabetes

Have an unstable illness e.g., thyroid gland dysfunction, uncontrolled mood disorders (e.g., depression, anxiety, bipolar)

Diagnosed with any known metabolic or endocrine dysfunctions e.g., diabetes, NAFLD, hyperinsulinaemia, hypoglycaemia

Trial design

Design model

Crossover

Treatments tested in this trial

  • TRPTI

    Dietary supplement

    Participants will receive a single capsule of 150mg TRPTI

  • Placebo

    Other intervention

    Participants will receive a single capsule of placebo

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: TRPTIExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in plasma GLP-1 concentration

Change from baseline in plasma GLP-1 concentration at each individual post-dose time point (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3, 4, 5, 6, 7, and 8-hours post-dose). Comparing TRPTI 150 mg to placebo

Time frame
Baseline to 8hrs

Secondary outcomes

1

GLP-1 area under the curve (AUC)

GLP-1 area under the curve (AUC) 0: total (0-8 h) and pre-defined blocks (0-15 min, 15 min-2 h, 2-4 h, 4-6 h, 6-8 h). Comparing TRPTI 150 mg to placebo

Time frame
Baseline to 8hrs
2

Change from baseline at each individual time point for: GIP

Change from baseline at each individual time point for: GIP

Time frame
Baseline to 8hrs
3

Change from baseline at each individual time point for: DPP-4 (dipeptidyl peptidase-4)

Change from baseline at each individual time point for: DPP-4 (dipeptidyl peptidase-4)

Time frame
Baseline to 8hrs
4

Change from baseline at each individual time point for: glucose

Change from baseline at each individual time point for: glucose

Time frame
Baseline to 8hrs

Other outcomes

1

Exploratory: Change from baseline at each individual time point for glucagon

Exploratory: Change from baseline at each individual time point for glucagon

Time frame
Baseline to 8 hours
2

Exploratory: Change from baseline at each individual time point for PYY (peptide YY)

Exploratory: Change from baseline at each individual time point for PYY (peptide YY)

Time frame
Baseline to 8 hours
3

Exploratory: AUC (total and blocks) for glucagon

AUC (total and blocks) for glucagon

Time frame
Baseline to 8 hours
4

Exploratory: AUC (total and blocks) for PYY

AUC (total and blocks) for PYY

Time frame
Baseline to 8 hours

Sponsors 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

This trial is not recruiting at the moment. You can still explore other options: