Cinnamon and Withania on Weight Loss

Obesity Clinical Trial

Official title:

Effect on Weight Loss of an Oral Association of Cinnamon Bark (Cinnamomum Cassia) and Withania Somnifera in Adult Patients With Overweight or Obesity: a Randomized, Prospective, Placebo-controlled, Multicenter, Cross-over, Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05210218
• Other study ID #: CE5115
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: January 2022
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Dietary Supplement:
• 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)
• placebo
cellulose

Locations

Country	Name	City	State
Italy	Sapienza University of Rome	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight change	body mass change in kg	at baseline and at every follow up visit, through study completion, an average of 10 weeks
Secondary	waist circumference change	waist circumference change in cm	at baseline and at every follow up visit through study completion, an average of 10 weeks