Cinnamon and Withania on Weight Loss

NCT ID: NCT05210218

Last Updated: 2022-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-06-01

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Cinnamomum cassia (CC) and Withania somnifera (WS) (300 mg+150mg, respectively)

Intervention Type: 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)

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).

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

cellulose

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

placebo

cellulose

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Lucio Gnessi

Full Professor MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sapienza University of Rome

Roma, RM, Italy

Countries

Italy

Other Identifiers

CE5115

Identifier Type: -

Identifier Source: org_study_id