NCT05031702

Brief Summary

Camellia Sinensis leaf extract contributes to increasing energy expenditure and calorie consumption by increasing thermogenesis. The purpose of this study is to evaluate the efficacy of Camellia Sinensis on basal metabolism and body composition in overweight women or with obesity in postmenopause.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
Last Updated

March 3, 2022

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

August 27, 2021

Last Update Submit

February 15, 2022

Conditions

Postmenopausal Disorder

Outcome Measures

Primary Outcomes (2)

  • Changes on energy expenditure

    Basal metabolic rate (Kcal/day)

    Changes from baseline energy expenditure at 4 and at 8 weeks

  • Changes on energy expenditure

    24 h urinary nitrogen (g/24 h)

    Changes from baseline energy expenditure at 4 and at 8 weeks

Secondary Outcomes (15)

  • Changes on body composition

    Changes from baseline body composition at 4 and at 8 weeks

  • Changes on anthropometry

    Changes from baseline anthropometry at 4 and at 8 weeks

  • Changes on anthropometry

    Changes from baseline anthropometry at 4 and at 8 weeks

  • Changes on anthropometry

    Changes from baseline anthropometry at 4 and at 8 weeks

  • Changes on insulin resistance

    Changes from baseline insulin resistance at 4 and at 8 weeks

  • +10 more secondary outcomes

Study Arms (2)

Dietary supplement

ACTIVE COMPARATOR

Extract from Camellia Sinensis leaf

Dietary Supplement: Camellia Sinensis leaf extract

Placebo

PLACEBO COMPARATOR

Tablets of the same size as the active component

Combination Product: Placebo

Interventions

Camellia Sinensis leaf extractDIETARY_SUPPLEMENT

2 tablets per day of 150 mg (1 before lunch and 1 before dinner)

Dietary supplement
PlaceboCOMBINATION_PRODUCT

2 tablets per day of 150 mg (1 before lunch and 1 before dinner)

Placebo

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopause
  • Overweight or obesity class I-II (Body Mass Index 25-39,9 Kg/m2)

You may not qualify if:

  • Changes in heart rhythm
  • Intolerance or allergy to components
  • Obesity class III (Body Mass Index \> 40 Kg/m2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mariangela Rondanelli

Pavia, 27100, Italy

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 2, 2021

Study Start

March 8, 2021

Primary Completion

January 3, 2022

Study Completion

July 25, 2022

Last Updated

March 3, 2022

Record last verified: 2021-08

Locations

IT(1)