Cinnamon and Withania on Weight Loss

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Cinnamomum cassia (CC) and Withania somnifera (WS) (300 mg+150mg, respectively); Dietary supplement: placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00161
      • Sapienza University of Rome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mildly hypocaloric diet + CC 300 mg +WS 150 mg tid; 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).	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 Comparator: mildly hypocaloric diet + placebo tid; 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).	Dietary supplement: placebo; cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight change	body mass change in kg	at baseline and at every follow up visit, through study completion, an average of 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
waist circumference change	waist circumference change in cm	at baseline and at every follow up visit through study completion, an average of 10 weeks

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: CE5115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: upon reasonable request to the corresponding author

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No