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Effect of Aqueous Extracts of Cissus Quadrangularis and Dichrostachys Glomerata on GLP-1 Concentration and DPP-4 Activity in Overweight and Obese Adults Phase 1, Phase 2 248 Dietary

Active, not recruiting
Clinical Trial NCT06827002 is designed to study Treatment for Obesity and Overweight, Appetite Regulation. It is a Phase 1 Phase 2 interventional study that is active, not recruiting, having started on February 12, 2023, with plans to enroll 248 participants. Led by University of Yaounde 1, it is expected to complete by January 1, 2026. The latest data from ClinicalTrials.gov was last updated on October 14, 2025.
Brief Summary
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...Show More
Detailed Description
Obesity is a health burden affecting over 2.3 billion people of all ages globally. The development and progression of obesity involve a complex pathogenesis, and several drugs have been developed to target these pathways. In recent years, dipeptidyl peptidase-4 (DPP-4) inhibitors or gliptins, such as sitagliptin, saxagliptin, and vildagliptin, have been considered as a viable obesity management option. Gliptins inhib...Show More
Official Title

Cissus Quadrangularis (CQR-300®) and Dichrostachys Glomerata (Dyglomera®) Extracts Increase GLP-1 Levels and Inhibit Dipeptidyl Phosphate-4 Activity in Healthy Overweight and Obese Adults

Conditions
Obesity and OverweightAppetite Regulation
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • JAOFCissusDyglo
  • JAOF122025 (Other Grant/Funding Number) (J & A Oben Foundation)
  • N°2014/08/488/CE/CNERSH/SP (Other Identifier) (National Ethics Committee of Cameroon)
  • BTC-JIRB2023-084 (Other Identifier) (University of Yaounde I IRB)
NCT ID Number
NCT06827002
Start Date (Actual)
2023-02-12
Last Update Posted
2025-10-14
Completion Date (Estimated)
2026-01
Enrollment (Estimated)
248
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Active, not recruiting
Keywords
Natural Products
GLP-1
DDP-4 Inhibitors
Obesity management
Appetite regulation
CQR-300®
Dyglomera®
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Placebo ComparatorPlacebo 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 12 weeks. Participants will be instructed to maintain their usual lifestyle and dietary habits and to report any delays in taking the capsules.
Dextrin
Placebo capsules containing 400 mg of dextrin, looking identical to DGE and CQE were also procured from Gateway Health Alliances, Fairfield, California, USA.
ExperimentalDichrostachys 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 12 weeks. Participants will be instructed to maintain their usual lifestyle and dietary habits and to report any delays in taking the capsules.
Dichrostachys glomerata
DGE were procured from Gateway Health Alliances, Fairfield in 400 mg and 300 mg capsules.
ExperimentalCissus 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 12 weeks. Participants will be instructed to maintain their usual lifestyle and dietary habits and to report any delays in taking the capsules.
Cissus quadrangularia
CQR-300® were procured from Gateway Health Alliances, Fairfield in 400 mg and 300 mg capsules.
Active ComparatorSemaglutide 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 to 7 to 14mg). Participants will be instructed to maintain their usual lifestyle and dietary habits and to report any delays in taking the capsules.
Semaglutide (Rybelsus®)
Oral semaglutide (Rybelsus®) was purchased and then repackaged into capsules looking identical to DGE, CQE and placebo capsules.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Effect of Dyglomera® and CQR-300® on participants GLP-1 level
Description: GLP-1 levels will be determined in pg/mL using the RayBio® GLP-1 ELISA kit.
Baseline (Week 0), Week 4, Week 8, and Week 12
Effect of Dyglomera® and CQR-300® on participants BMI
BMI will then be calculated as follows: BMI (kg/m²)=Weight in Kg/Height in meter²
Baseline (Week 0), Week 4, Week 8, and Week 12
Effect of Dyglomera® and CQR-300® on participants Fasting blood glucose
Glucose levels will be measured in blood samples taken from each participant after a 12-hour fast at baseline (Week 0), Week 4, Week 8, and Week 12 using the glucose oxidase-peroxidase enzymatic method with a OneTouch Ultra 2 glucometer. Unit of measure: mg/dL
Baseline (Week 0), Week 4, Week 8, and Week 12
Effect of Dyglomera® and CQR-300® on participants DPP4 activity
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.
Baseline (Week 0), Week 4, Week 8, and Week 12
Effect of Dyglomera® and CQR-300® on participants Lipid Profile
Blood lipid levels (cholesterol, triglycerides, and HDL-c) will be measured in blood samples taken from each participant after a 12-hour fast at baseline (Week 0), Week 4, Week 8, and Week 12 using ChronoLab commercial kits according to the protocol of the manufacturers. LDL-c will be assessed using the Friedewald et al. formula. LDL-c = Plasma-c - HDL-c - Total Plasma triglyceride/5 Unit of measure: mg/dL
Baseline (Week 0), Week 4, Week 8, and Week 12
Effect of Dyglomera® and CQR-300® on participants Body Fat percentage
The body fat percentage (%) was measured using an impedance meter at visits 1, 2 (week 0 or baseline), 3 (week 4), 4 (week 8), and 5 (week 12).
Baseline (Week 0), Week 4, Week 8, and Week 12
Effect of Dyglomera® and CQR-300® on participants Body weight
Body weight will be measured in Kg using a TANITA brand scale at Visits 1, 2 (Week 0/Baseline), 3 (Week 4), 4 (Week 8), and 5 (Week 12).
Baseline (Week 0), Week 4, Week 8, and Week 12
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Effect of Dyglomera® and CQR-300® on participants' energy Intake
Participants will maintain a food diary for seven consecutive days (the last week of each study period), recording all foods, drinks, and snacks consumed. Food intake will be recorded in household measurements and converted into grams using manufacturer labels where applicable. Nutrient intake (carbohydrates, lipids, and proteins) will then be quantified in grams using the FAO food composition table for Cameroon. Energy intake will be calculated as follows: EI (Kcal/day) = ECarb + ELip + EProt where: ECarb(Kcal/day)=Amount of carb ingested (g) x 4 Kcal/7 Eprot (Kcal/day)=Amount of carb/prot ingested (g) x 4 Kcal/7 ELip (Kcal/day)=Amount of lipid ingested (g) x 9 Kcal/7 Considering that: 1 g carbohydrate or protein = 4 Kcal and 1 g lipid = 9 kcal
Week 12
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
University of Yaounde 1 logoUniversity of Yaounde 1
J & A Oben Foundation logoJ & A Oben Foundation
Study Responsible Party
Pr. Julius Oben, Principal Investigator, Head of Department, University of Yaounde 1
No contact data.
1 Study Locations in 1 Countries

Centre Region

University of Yaounde 1, Yaoundé, Centre Region, 00237, Cameroon