NCT05210218

Cinnamon and Withania on Weight Loss

Completed NA Last updated 27 January 2022

What this trial tests

NA trial testing Cinnamomum cassia (CC) and Withania somnifera (WS) (300 mg+150mg, respectively) in Obesity in 40 participants. Completed in 1 June 2019.

Timeline

1 January 2018

Primary endpoint
1 January 2019

1 June 2019

Quick facts

Lead sponsor	University of Roma La Sapienza
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	1 January 2018
Primary completion	1 January 2019
Estimated completion	1 June 2019
Sites	1 location across Italy

Drugs / interventions tested

• Cinnamomum cassia (CC) and Withania somnifera (WS) (300 mg+150mg, respectively)
• placebo

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

University of Roma La Sapienza

Who can join

Adults 25 to 75, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

With the prevalence of obesity soaring and the absence of an effective and safe treatment that is low-cost and always feasible, the use of food supplements has gained attention for the potential benefits in the absence of significant safety concerns. Cinnamon (CC) and Withania somnifera (WS) are plant-based supplements reported to be effective in improving metabolic health and body composition, the first mainly acting on insulin resistance and the second on energy expenditure and leptin resistance, as shown in preclinical and some clinical studies. Their association, possibly synergistic leveraging different mechanisms of action, has never been studied.

This was a double-blind placebo-controlled study. Patients with overweight or obesity were prescribed a mildly hypocaloric diet with CC 300 mg plus WS 150 mg tid for 4 weeks in a cross over design and anthropometric parameters together with safety outcomes were collected.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Emerging Vistas for the Nutraceutical <i>Withania somnifera</i> in Inflammaging.
   Basudkar V, Gujrati G, Ajgaonkar S, Gandhi M, et al · · 2024 · cited 17× · PMID 38794167 · DOI 10.3390/ph17050597