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Effect of Coffee and Tea Consumption on Adolescent Weight Control

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ClinicalTrials.gov Identifier: NCT05181176
Recruitment Status : Recruiting
First Posted : January 6, 2022
Last Update Posted : January 24, 2022
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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.


Condition or disease Intervention/treatment Phase
Body Weight Dietary Supplement: Coffee Dietary Supplement: Green tea Dietary Supplement: Herbal tea (placebo) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Coffee and Tea Consumption on Adolescent Weight Control - a Randomized Clinical Trial
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Coffee
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
3 weight-loss interventions comprised of a similar dietary recommendation with either coffee (coffee group), tea (tea group) or placebo (herbal tea).

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

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




Primary Outcome Measures :
  1. effect tea and coffee consumption on body weight [ Time Frame: 6 months ]
    change in BMI Z score


Secondary Outcome Measures :
  1. effect tea and coffee consumption on body fat [ Time Frame: 6 months ]
    change in fat percentage analysis using bio electrical impedance analysis



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Exclusion criteria included major medical, chronic use of medication that may affect study outcomes or regular intake of some tea or coffee (individual for whom the intervention would likely produce relatively little change in habitual intake).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05181176


Contacts
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Contact: Hadar Moran Lev 00972527360713 hadarlev6@gmail.com
Contact: Hadar Moran Lev, MD 00972527360713 hadarlev6@gmail.com

Locations
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Israel
Pediatric Gastroenterology Unit Recruiting
Tel Aviv, Israel, 662034
Contact: Hadar Moran Lev, MD    00972527360713    hadarlev6@gmail.com   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Hadar Moran Lev, MD Pediatric Gastroenterology
Publications:
Vardi P, Shahaf-Alkalai K, Sprecher E, et al. Components of the metabolic syndrome (MTS), hyperinsulinemia, and insulin resistance in obese Israeli children and adolescents. Diabetes Metab Syndr Clin Res Rev. 2007;1(2):97-103

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT05181176    
Other Study ID Numbers: TLV-18-0166
First Posted: January 6, 2022    Key Record Dates
Last Update Posted: January 24, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: the individual participant data will be anonymous to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tel-Aviv Sourasky Medical Center:
Obesity
Additional relevant MeSH terms:
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Body Weight