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OpenTrials
Completed

NCT Number: NCT05210218

Cinnamon and Withania on Weight Loss

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sapienza University of Rome

Roma, RM, 00161, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Placebo

Dietary Supplement

cellulose

Primary outcomes

  1. weight change

    Time frame: at baseline and at every follow up visit, through study completion, an average of 10 weeks

    body mass change in kg

Secondary outcomes

  1. waist circumference change

    Time frame: at baseline and at every follow up visit through study completion, an average of 10 weeks

    waist circumference change in cm

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 27, 2022
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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