Cinnamon and Withania on Weight Loss
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cinnamomum cassia (CC) and Withania somnifera (WS) (300 mg+150mg, respectively)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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
Sites / Locations
- Sapienza University of Rome
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
mildly hypocaloric diet + CC 300 mg +WS 150 mg tid
mildly hypocaloric diet + placebo tid
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
weight change
body mass change in kg
Secondary Outcome Measures
waist circumference change
waist circumference change in cm
Full Information
NCT ID
NCT05210218
First Posted
December 29, 2021
Last Updated
January 13, 2022
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT05210218
Brief Title
Cinnamon and Withania on Weight Loss
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mildly hypocaloric diet + CC 300 mg +WS 150 mg tid
Arm Type
Experimental
Arm Description
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).
Arm Title
mildly hypocaloric diet + placebo tid
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Cinnamomum cassia (CC) and Withania somnifera (WS) (300 mg+150mg, respectively)
Intervention Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
cellulose
Primary Outcome Measure Information:
Title
weight change
Description
body mass change in kg
Time Frame
at baseline and at every follow up visit, through study completion, an average of 10 weeks
Secondary Outcome Measure Information:
Title
waist circumference change
Description
waist circumference change in cm
Time Frame
at baseline and at every follow up visit through study completion, an average of 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sapienza University of Rome
City
Roma
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
upon reasonable request to the corresponding author
Learn more about this trial
Cinnamon and Withania on Weight Loss
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