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Obesity and OverweightPhase 1/2NCT06827002

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

A Phase 1/2 study testing Dichrostachys glomerata, Cissus quadrangularia and Dextrin in people with Obesity and Overweight and Appetite Regulation, run by University of Yaounde 1 at 1 site in Cameroon.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity and Overweight, Appetite Regulation
What is being tested?
Dichrostachys glomerata, Cissus quadrangularia and Dextrin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
1 siteCameroon
Study dates
29 Mar 2023to Aug 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Cameroon1 site

  • University of Yaounde 1

    Yaoundé, Centre Region, 00237

Other trials in Cameroon

About this study

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

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.

Read the 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 inhibit DPP-4, an enzyme known to deactivate the GLP-1 hormone, contributing to the development and progression of obesity and other metabolic diseases. GLP-1 is one of the important incretin hormones secreted in the L-cells of the gut for the maintenance of blood sugar homeostasis. It exhibits other pleiotropic effects through its receptors in the liver, brain, and stomach to delay gastric emptying, reduce appetite, and induce significant weight loss. In healthy individuals, GLP-1 has a half-life of >2 minutes due to the activities of DPP-4 . Some studies have observed higher DPP-4 levels in obese individuals, further reducing the incretin effects of GLP-1. Gliptins are primarily invented to manage type 2 diabetes. However, their weight loss effects are quite significant, presenting as a potent management option for obesity.

Synthetically produced drugs are often associated with side effects and contraindications. For conditions such as obesity, patients often require unique management options due to sensitivity and the high likelihood of comorbidities. For instance, obese individuals are more vulnerable to pancreatitis and pancreatic cancer, whereas gliptins are associated with a high incidence of acute pancreatitis. Gliptins also present other side effects such as upper respiratory infections, headache, urinary tract infections, arthralgia, and in severe cases, Stevens-Johnson syndrome. Cost-wise, gliptins are considerably expensive. The current FDA-approved gliptins are intended for the management of diabetes. Prescribing them for obesity may lead to higher demand and prices as well as scarcity. Hence, there is a need for a wider range of safe, cost-effective, and potent alternatives.

Natural products continue to emerge as potential drug leads for several metabolic disease conditions due to their potency and low toxicity. DGE (Dichrostachys glomerata), a popular Cameroonian spice, and CQE (Cissus quadrangularis), an ornamental and medicinal plant growing in Africa and Asia, have shown tremendous effects on weight loss. A recent study showed that DGE induced 22.85% weight loss in 60 subjects in 12 weeks. In a double-blind placebo-controlled study involving 35 subjects, CQE reduced body fat by 12.8% in 8 weeks. The mechanism of these two extracts is not fully understood. It has been proposed that DGE and CQE are anorectic. Some studies suggested that DGE and CQE reduced food intake through increased adiponectin secretion and the AMPK pathway.

Additionally, CQE was shown to boost serotonin levels. Serotonin has received much attention in weight loss research in the past. It has been implicated for its appetite-suppressing effect on the arcuate nucleus hypothalamus, a region responsible for food intake and energy expenditure.

Up to the present, no study has investigated the effect of DGE or CQE on GLP-1 or DPP-4 levels. Hence, this study aims to evaluate the efficacy of DGE and CQE as potent alternatives to gliptins in obesity management.

Being tested
Dichrostachys glomerata, Cissus quadrangularia, Dextrin, Semaglutide (Rybelsus®)
Keywords
Natural Products, GLP-1, DDP-4 Inhibitors, Obesity management, Appetite regulation, CQR-300®, Dyglomera®
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dichrostachys glomerataDrug

    Also called Dyglomera®, DGE

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

  • Cissus quadrangulariaDrug

    Also called CQR-300®, CQE

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

  • DextrinDrug

    Also called Placebo group

    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

    Also called semaglutide

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

Study groups in NCT06827002
Study groupRoleWhat they receive
Placebo GroupPlacebo comparator62 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.
Receives: Drug: Dextrin
Dichrostachys glomerata Extract (DGE) GroupExperimental62 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.
Receives: Drug: Dichrostachys glomerata
Cissus quadrangularia Extract (CQE) GroupExperimental62 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.
Receives: Drug: Cissus quadrangularia
Semaglutide GroupActive comparator62 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.
Receives: Drug: Semaglutide (Rybelsus®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of DGE and CQE on participants GLP-1 level

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

    Measured: Baseline (Week 0), Week 4, Week 8, Week 12 and Week 16

  2. Effect of DGE and CQE 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.

    Measured: Baseline (Week 0), Week 4, Week 8, Week 12 and Week 16

Secondary outcomes (6)

  1. Effect of DGE and CQE 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

    Measured: Week 16

  2. Effect of DGE and CQE 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, Week 12 and Week 16 using the glucose oxidase-peroxidase enzymatic method with a OneTouch Ultra 2 glucometer.

    Unit of measure: mg/dL

    Measured: Baseline (Week 0), Week 4, Week 8, Week 12 and Week 16

  3. Effect of DGE and CQE on participants BMI

    BMI will then be calculated as follows:

    BMI (kg/m²)=Weight in Kg/Height in meter²

    Measured: Baseline (Week 0), Week 4, Week 8, Week 12 and Week 16

  4. Effect of DGEand CQE on participants Body weight

    Body weight will be measured in Kg using a TANITA brand scale at Visits (baseline (Week 0), Week 4, Week 8, Week 12 and Week 16)

    Measured: Baseline (Week 0), Week 4, Week 8, Week 12 and Week 16

  5. Effect of DGE and CQE on participants Body Fat percentage

    The body fat percentage (%) was measured using an impedance meter at baseline (Week 0), Week 4, Week 8, Week 12 and Week 16

    Measured: Baseline (Week 0), Week 4, Week 8, Week 12 and Week 16

  6. Effect of DGE and CQE 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, Week 12 and Week 16 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

    Measured: Baseline (Week 0), Week 4, Week 8, Week 12 and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2025
  2. Study start29 Mar 2023
  3. Primary completion23 Feb 2026
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06827002
Sponsor's protocol ID
JAOFCissusDyglo
Other IDs
JAOF122025, N°2014/08/488/CE/CNERSH/SP, BTC-JIRB2023-084
Status last verified
May 2026
First submitted
29 Jan 2025
Last updated
15 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: * Metabolic parameters (Blood sugar, Blood lipid), * Anthroprmetric measures (height, weight, BMI and body fat percentage) * DPP-4 and GLP-1 levels data collected through out the study

Publications

  • Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.

    PubMed 4337382

  • 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.

  • 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.

    PubMed 26288659

  • 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.

    PubMed 26177483

  • 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.

    PubMed 27659407

  • 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.

    PubMed 23622135

  • 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.

    PubMed 28450900

  • 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.

    PubMed 15655721

  • 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.

    PubMed 24323912

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dichrostachys glomerata, Cissus quadrangularia and Dextrin in people with Obesity and Overweight and Appetite Regulation, run by University of Yaounde 1 at 1 site in Cameroon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06827002, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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