NCT05181176

Brief Summary

Introduction: The influence of tea or coffee supplementation on body weight in adolescents has never been tested. The aim of the present study was to investigate the effect of tea and coffee consumption on body weight and body fat in an obese adolescent population. Methods: Randomized clinical trial, parallel group study comparing 3 weight loss interventions comprised of a similar dietary recommendation with either coffee (coffee group), tea (tea group) or placebo (herbal tea). Sociodemographic data and medical history details were retrieved from medical files. The body mass index Z (BMI Z) score and fat percentage as measured by bioelectrical impedance were compared between groups at 3 and 6 months.

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
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

January 24, 2022

Status Verified

December 1, 2021

Enrollment Period

1.9 years

First QC Date

December 6, 2021

Last Update Submit

January 7, 2022

Conditions

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

  • effect tea and coffee consumption on body weight

    change in BMI Z score

    6 months

Secondary Outcomes (1)

  • effect tea and coffee consumption on body fat

    6 months

Study Arms (3)

Coffee

EXPERIMENTAL

The coffee group was instructed to consume 2 cups of coffee a day, the amount that was previously described as beneficial in epidemiological studies and safe for children and adolescence. Each cup of coffee contains 250 ml of coffee, which contains approximately 80 mg of caffeine. The children were allowed to add milk to the coffee and sweeten it with artificial sweetener

Dietary Supplement: Coffee

Green Tea

EXPERIMENTAL

The green tea group will be instructed to drink 3 cups (230CC) of Chinese green tea (Wissotzky Tea Israel Ltd). Each tea bag contains 500 g of fine dried herb parts. Each cup contains 84 mg total catechin and 32 mg caffeine. The participants were instructed to leave the tea bag for 2 minutes before drinking.

Dietary Supplement: Green tea

Herbal tea

PLACEBO COMPARATOR

The control group consumed 3 cups a day of Wissotzky- kid drink (Wissotzky Tea Israel Ltd), which is a drink that is marketed for children containing an infusion of fruits and plants. Each tea bag contains 2.7 gr plants parts with no evidence of polyphenols or caffeine.

Dietary Supplement: Herbal tea (placebo)

Interventions

CoffeeDIETARY_SUPPLEMENT

3 weight-loss interventions comprised of a similar dietary recommendation with either coffee (coffee group), tea (tea group) or placebo (herbal tea).

Coffee
Green teaDIETARY_SUPPLEMENT

3 weight-loss interventions comprised of a similar dietary recommendation with either coffee (coffee group), tea (tea group) or placebo (herbal tea).

Green Tea
Herbal tea (placebo)DIETARY_SUPPLEMENT

3 weight-loss interventions comprised of a similar dietary recommendation with either coffee (coffee group), tea (tea group) or placebo (herbal tea).

Herbal tea

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents aged 12-17 years with BMI in the 95th percentile or higher were eligible for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Gastroenterology Unit

Tel Aviv, 662034, Israel

RECRUITING

Related Publications (32)

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MeSH Terms

Conditions

Body WeightObesity

Interventions

CoffeeTeaTeas, Herbal

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Hadar Moran Lev, MD

    Pediatric Gastroenterology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadar Moran Lev

CONTACT

Hadar Moran Lev, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial, parallel group study comparing 3 weight loss interventions comprised of a similar dietary recommendation with either coffee (coffee group), tea (tea group) or placebo (herbal tea).
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2021

First Posted

January 6, 2022

Study Start

January 1, 2021

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

January 24, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

the individual participant data will be anonymous to other researchers

Locations