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

Sponsor
University of Yaounde 1
Study ID
NCT06827002
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Appetite Regulation
  • Obesity and Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 29, 2023
Status verified
May 2026
Primary completion
Feb 23, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
248 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Group
    62 participants aged 18-65 with a BMI between 25 - 34 kg/m 2 randomly assigned to the placebo group will be administered a 400 mg dextrin capsule daily for 16 weeks. Participants will be instructed to maintain their usual lifestyle and dietary habits and to report any delays in taking the capsules.
  • Experimental: Dichrostachys glomerata Extract (DGE) Group
    62 participants aged 18-65 with a BMI between 25 - 34 kg/m 2 randomly assigned to the DGE group will be administered 400mg DGE capsule daily for 16 weeks. Participants will be instructed to maintain their usual lifestyle and dietary habits and to report any delays in taking the capsules.
  • Experimental: Cissus quadrangularia Extract (CQE) Group
    62 participants aged 18-65 with a BMI between 25 - 30 kg/m 2 randomly assigned to the CQE group will be administered 300mg CQE capsule daily for 16 weeks. Participants will be instructed to maintain their usual lifestyle and dietary habits and to report any delays in taking the capsules.
  • Active Comparator: Semaglutide Group
    62 participants aged 18-65 with a BMI between 25 - 34 kg/m 2 randomly assigned to the semaglutide group will be administered a repackaged Oral semaglutide (Rybelsus®) capsule daily (4-week dose escalation from 3 (week 0-4) to 7 (week 4-8) to 14mg (week 8-16)). Participants will be instructed to maintain their usual lifestyle and dietary habits and to report any delays in taking the capsules.

Primary Outcome Measure

Effect of DGE and CQE on participants GLP-1 level [ Time Frame: Baseline (Week 0), Week 4, Week 8, Week 12 and Week 16 ]

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