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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mildly hypocaloric diet + CC 300 mg +WS 150 mg tid | Experimental | 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). |
|
| mildly hypocaloric diet + placebo tid | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cinnamomum cassia (CC) and Withania somnifera (WS) (300 mg+150mg, respectively) | Dietary Supplement | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza University of Rome | Roma | RM | 00161 | Italy |
upon reasonable request to the corresponding author
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| placebo | Dietary Supplement | cellulose |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |