Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCinnamomum 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)
DIETARY_SUPPLEMENTplacebo
cellulose
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight change | at baseline and at every follow up visit, through study completion, an average of 10 weeks | body mass change in kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| waist circumference change | at baseline and at every follow up visit through study completion, an average of 10 weeks | waist circumference change in cm |
Countries
Italy
Outcome results
None listed