parallel randomized trial

NCT06827002

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

Overweight or obesity without diabetes (adults)NCT06827002S001538

Design

Randomized: 248
Start year: 2023
Treatment: 16 weeks, follow-up 16 weeks
Countries: Cameroon
Sponsor: University of Yaounde 1; J and A Oben Foundation (mixed)
Eligibility: adults; BMI 25 to 34.9; stable weight; no uncontrolled diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	lifestyle: none	62	58
A2	Dichrostachys glomerata extract Dichrostachys glomerata extract 400 mg	lifestyle: none	62	58
A3	Cissus quadrangularis extract Cissus quadrangularis extract 300 mg	lifestyle: none	62	56
A4	Semaglutide 14 mg oral once daily (original tablet) Oral semaglutide 14 mg	lifestyle: none	62	56

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Placebo A1	Dichrostachys glomerata extract A2	Cissus quadrangularis extract A3	Semaglutide 14 mg oral once daily (original tablet) A4	Whole trial ALL
age	mean (years)					41.3
age	se (years)					0.55
bmi	mean (kg/m2)					30.7
female	n					126
weight	mean (kg)	81.97	81.96	81.55	81.80

Results

12 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Percent body weight change (4 lines; O10)

Week	Arm	Statistic	Estimate	Events / N	Detail
16	A1	percent change	-0.7 percent	58	not stated; completers; R0020681:Table 4
16	A2	percent change	-5.2 percent	58	not stated; completers; R0020681:Table 4
16	A3	percent change	-5.8 percent	56	not stated; completers; R0020681:Table 4
16	A4	percent change	-5.9 percent	56	not stated; completers; R0020681:Table 4

Serious adverse events (4 lines; O25)

Arm	Statistic	Detail
A1	events	not stated; other; R0020681:Results
A2	events	not stated; other; R0020681:Results
A3	events	not stated; other; R0020681:Results
A4	events	not stated; other; R0020681:Results

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 62	not stated; randomized; felt unwell after week 2; R0020681:Figure 1
A3	events	2 / 62	not stated; randomized; stomach discomfort; R0020681:Figure 1
A4	events	3 / 62	not stated; randomized; discomfort; R0020681:Figure 1

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A3	events				2 / 62	not stated; randomized; stomach discomfort; R0020681:Figure 1