Cinnamon and Withania on Weight Loss

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: placebo; Dietary Supplement: Cinnamomum cassia (CC) and Withania somnifera (WS) (300 mg+150mg, respectively)

• Registration Number: NCT05210218
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-06-01
• Study First Submitted: 2021-12-29
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-13
• Last Update Submitted: 2022-01-13
• Study First Posted: 2022-01-27
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• age range: 25-75 years
• overweight or obesity (BMI range: 26-35)

Exclusion Criteria

• heart failure
• congenital cardiomyopathies
• episodes of tachy/brady-arrythmias
• acute myocardial infarction within 3 months from the enrollment
• inability or unwillingness to provide informed consent
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
mildly hypocaloric diet + placebo tid	placebo	Each patient took the placebo (i.e., the same amount of cellulose). All patients received a mildly hypocaloric diet (i.e., -20% of the usual caloric intake as assessed by a 24-hour dietary recall).
mildly hypocaloric diet + CC 300 mg +WS 150 mg tid	Cinnamomum cassia (CC) and Withania somnifera (WS) (300 mg+150mg, respectively)	The study product, in a capsule formulation, was made by the extract of Cinnamomum cassia (CC) and Withania somnifera (WS) (300 mg+150mg, respectively) (Nutrintech Ltd., London, UK) to be taken three times a day. All patients received a mildly hypocaloric diet (i.e., -20% of the usual caloric intake as assessed by a 24-hour dietary recall).

Primary Outcome Measures

Name	Time	Method
weight change	at baseline and at every follow up visit, through study completion, an average of 10 weeks	body mass change in kg

Secondary Outcome Measures

Name	Time	Method
waist circumference change	at baseline and at every follow up visit through study completion, an average of 10 weeks	waist circumference change in cm

Trial Locations

Locations (1)

Sapienza University of Rome; 🇮🇹 Roma, RM, Italy