Clinical trial

Effect of Aqueous Extracts of Cissus Quadrangularis and Dichrostachys Glomerata on GLP-1 Concentration and DPP-4 Activity in Overweight and Obese Adults

Active, not recruiting · Phase 1, Phase 2 · 1 countries · Registry ID NCT06827002

Active, not recruitingPhase 1, Phase 2Interventional

What this study is about

Obesity is a global health crisis affecting over 2.3 billion individuals worldwide. This prospective study aims to evaluate the comparative effects of standardised Cissus quadrangularis extract (CQE) and Dichrostachys glomerata extract (DGE) on obesity-related parameters, focusing on their impact on glucagon-like peptide-1 (GLP-1) levels and dipeptidyl peptidase-4 (DPP-4) enzyme activity in obese subjects. Parameters such as GLP-1 levels, DPP-4 activity, food intake, satiety, body weight, blood lipids, fasting blood glucose, and visceral fat mass will be measured at baseline and various intervals. In our previous pre-clinical trial involving 18 adult male Wistar rats (150-200 g), randomly divided into three groups: a control group fed a normal diet, and two treatment groups receiving DGE (400 mg/kg) or CQE (300 mg/kg) alongside a normal diet, the results demonstrated that both DGE and CQE significantly increased GLP-1 levels and inhibited DPP-4 activity compared to the control group. These effects were associated with reduced food intake, body weight, and fasting blood glucose levels. Additionally, both extracts positively modified blood lipid profiles, with significant changes in HDL, LDL, and triglyceride levels. The findings suggest that DGE and CQE exert their anti-obesity effects through mechanisms involving GLP-1 enhancement and DPP-4 inhibition, offering potential therapeutic pathways for weight management and metabolic health. This prospective study aims to provide clinical evidence supporting the use of these plant extracts in addressing obesity and its related complications.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity and Overweight, Appetite Regulation

Full registry criteria

Inclusion Criteria: * Healthy males and non-pregnant/non-lactating females * Participants aged 18 to 65 years old * Participants with BMI between 25 and 34 kg/m² * Participants willing to comply with the study protocol Exclusion Criteria: * Participants younger than 18 years or older than 65 years * Participants not available for the study period * Morbid obesity (BMI \> 34.9 kg/m²) * Diabetes mellitus requiring daily insulin management * Pregnancy or breastfeeding * Active infection * Systemic diseases, including HIV/AIDS, Active hepatitis, Clinical signs of active malignancy within the past 5 years * Use of any medication or natural health product that might affect the parameters of interest in this study

Treatments and study arms

Dichrostachys glomerata

Drug

DGE were procured from Gateway Health Alliances, Fairfield in 400 mg and 300 mg capsules.

Cissus quadrangularia

Drug

CQR-300® were procured from Gateway Health Alliances, Fairfield in 400 mg and 300 mg capsules.

Dextrin

Drug

Placebo capsules containing 400 mg of dextrin, looking identical to DGE and CQE were also procured from Gateway Health Alliances, Fairfield, California, USA.

Semaglutide (Rybelsus®)

Drug

Oral semaglutide (Rybelsus®) was purchased and then repackaged into capsules looking identical to DGE, CQE and placebo capsules.

Primary outcomes

Effect of DGE and CQE on participants GLP-1 levelBaseline (Week 0), Week 4, Week 8, Week 12 and Week 16

Description: GLP-1 levels will be determined in pg/mL using the RayBio® GLP-1 ELISA kit.

Effect of DGE and CQE on participants DPP4 activityBaseline (Week 0), Week 4, Week 8, Week 12 and Week 16

DPP-4 activity will be measured using Cayman's DPP-4 inhibitor screening assay kit according to the manufacturer's instructions. Unit of Measure: % Activity Remaining This will be determined using the calculation below: % activity remaining = (slope of test sample/positive control slope) × 100.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Yaounde 1🌐 Yaoundé, Centre Region, Cameroon