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

NCT06827002 | Active Not Recruiting Phase 1 FDA Drug

• 4 other identifiers: JAOFCissusDygloJAOF122025N°2014/08/488/CE/CNERSH/SPBTC-JIRB2023-084
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Obesity and Overweight; Appetite Regulation

Keywords

Natural Products; GLP-1; DDP-4 Inhibitors; Obesity management; Appetite regulation; CQR-300®; Dyglomera®

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Effect of Dyglomera® and CQR-300® on participants' energy Intake

  Week 12

Study Arms (4)

Placebo Group

PLACEBO COMPARATOR

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.

Drug: Dextrin

Dichrostachys glomerata Extract (DGE) Group

EXPERIMENTAL

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.

Drug: Dichrostachys glomerata

Cissus quadrangularia Extract (CQE) Group

EXPERIMENTAL

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.

Drug: Cissus quadrangularia

Semaglutide Group

ACTIVE COMPARATOR

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.

Drug: Semaglutide (Rybelsus®)

Interventions

Dichrostachys glomerata DRUG

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

Also known as: Dyglomera®, DGE

Dichrostachys glomerata Extract (DGE) Group

Cissus quadrangularia DRUG

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

Also known as: CQR-300®, CQE

Cissus quadrangularia Extract (CQE) Group

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.

Also known as: Placebo group

Placebo Group

Semaglutide (Rybelsus®) DRUG

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

Also known as: semaglutide

Semaglutide Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Yaounde 1: lead
• J & A Oben Foundation: collaborator

Study Sites (1)

University of Yaounde 1

Yaoundé, Centre Region, 00237, Cameroon

Location

Related Publications (9)

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  PMID: 4337382 BACKGROUND

• Youovop J, Takuissu G, Mbopda C, Nwang F, Ntentié R, Mbong M, Azantsa B, Singh H, Oben J. The effects of Dyglomera® (Dichrostachys glomerata extract) on body fat percentage and body weight: a randomized, double-blind, placebo-controlled clinical trial. Functional Foods in Health and Disease 2023, 13: 334-346.

  BACKGROUND

• Filipova EP, Uzunova KH, Vekov TY. Comparative analysis of therapeutic efficiency and costs (experience in Bulgaria) of oral antidiabetic therapies based on glitazones and gliptins. Diabetol Metab Syndr. 2015 Jul 16;7:63. doi: 10.1186/s13098-015-0059-7. eCollection 2015.

  PMID: 26288659 BACKGROUND

• Filippatos TD, Panagiotopoulou TV, Elisaf MS. Adverse Effects of GLP-1 Receptor Agonists. Rev Diabet Stud. 2014 Fall-Winter;11(3-4):202-30. doi: 10.1900/RDS.2014.11.202. Epub 2015 Feb 10.

  PMID: 26177483 BACKGROUND

• Tkac I, Raz I. Combined Analysis of Three Large Interventional Trials With Gliptins Indicates Increased Incidence of Acute Pancreatitis in Patients With Type 2 Diabetes. Diabetes Care. 2017 Feb;40(2):284-286. doi: 10.2337/dc15-1707. Epub 2016 Sep 22.

  PMID: 27659407 BACKGROUND

• Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.

  PMID: 23622135 BACKGROUND

• Valerio CM, de Almeida JS, Moreira RO, Aguiar LBS, Siciliano PO, Carvalho DP, Godoy-Matos AF. Dipeptidyl peptidase-4 levels are increased and partially related to body fat distribution in patients with familial partial lipodystrophy type 2. Diabetol Metab Syndr. 2017 Apr 24;9:26. doi: 10.1186/s13098-017-0226-0. eCollection 2017.

  PMID: 28450900 BACKGROUND

• Ahren B, Schmitz O. GLP-1 receptor agonists and DPP-4 inhibitors in the treatment of type 2 diabetes. Horm Metab Res. 2004 Nov-Dec;36(11-12):867-76. doi: 10.1055/s-2004-826178.

  PMID: 15655721 BACKGROUND

• van Bloemendaal L, Ten Kulve JS, la Fleur SE, Ijzerman RG, Diamant M. Effects of glucagon-like peptide 1 on appetite and body weight: focus on the CNS. J Endocrinol. 2014 Mar 7;221(1):T1-16. doi: 10.1530/JOE-13-0414. Print 2014 Apr.

  PMID: 24323912 BACKGROUND

Related Links

• WHO. Obesity and Overweight.

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Dextrins; semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Julius E Oben, PhD

  University of Yaounde 1

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Model Details: The study involves Two hundred and forty eight (248) overweight or obese participants (25 ≥ BMI ≤ 34), randomly divided into four groups: the placebo, DGE group, CQE and semaglutide groups.

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 14, 2025
• Study Start: February 12, 2023
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)