Cinnamon and Withania on Weight Loss

NCT05210218 | Completed

• 1 other identifier: CE5115
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• weight change

  body mass change in kg

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

Secondary Outcomes (1)

• waist circumference change

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

Study Arms (2)

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).

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

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).

Dietary Supplement: placebo

Interventions

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)

mildly hypocaloric diet + CC 300 mg +WS 150 mg tid

placebo DIETARY_SUPPLEMENT

cellulose

mildly hypocaloric diet + placebo tid

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age range: 25-75 years
• overweight or obesity (BMI range: 26-35)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Roma, RM, 00161, Italy

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor MD PhD

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 27, 2022
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

IT (1)