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Body WeightNCT05181176

Effect of Coffee and Tea Consumption on Adolescent Weight Control

A study testing Coffee and Green tea in people with Body Weight, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Body Weight
What is being tested?
Coffee and Green tea
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
1 siteIsrael
Study dates
1 Jan 2021to 1 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Hadar Moran Lev contact

00972527360713

hadarlev6@gmail.com

Hadar Moran Lev, MD contact

00972527360713

hadarlev6@gmail.com

Israel1 site, 1 recruiting
  • Pediatric Gastroenterology Unit

    Tel Aviv, 662034

    Hadar Moran Lev, MD, 00972527360713, hadarlev6@gmail.com

    Recruiting

Other trials in Israel

About this study

Official title: Effect of Coffee and Tea Consumption on Adolescent Weight Control - a Randomized Clinical Trial

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.

Read the detailed description

Patient Population The participants were recruited at the at the Obesity Clinic in the Pediatric Gastroenterology Unit at "Dana Dwek" Children's Hospital from January 2018 and December 2020. The Obesity Clinic is a tertiary referral center for children and adolescent with obesity and its complication. Adolescents aged 12-17 years with BMI in the 95th percentile or higher were eligible for the study. 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).

Study Design This is a randomized clinical trial, parallel-group study comparing 3 weight loss interventions comprising standardized dietary recommendation either with coffee (coffee group) tea (tea group) or placebo (herbal tea). The study consists of 2 weeks run in period and 24 weeks treatment period.

Intervention The 3 groups received similar weight reducing interventions comprising diets that will differentiated only with regard to the recommendation for coffee or green tea consumption. The standard intervention included 2 weekly family-based counseling concerning nutritional education (low carbohydrate, low glycemic index diet), behavioral counseling and physical activity.

The coffee group instructed to consume 2 cups of coffee a day, amount that was previously describe 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.

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 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. 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 infusion of fruits and plants. Each tea bag contains 2.7 gr plants parts with no evidence of polyphenols or caffeine.

The tea was provided to the participants and adherence was ensured by 3 days dietary questioners at each visit and by collecting empty boxes every month.

Outcomes

Information retrieved from medical files of subjects included:

  1. Sociodemographic characteristics: age, sex
  2. Medical history: perinatal characteristics (birth weight, gestational age), medications and family history of cardio-metabolic diseases (diabetes, hypertension, dyslipidemia, cardiovascular disease, and cerebrovascular episodes) in first- and second-degree relatives.
  3. Physical examination: systolic and diastolic BP and anthropometric measurements (height, weight, calculated BMI and body fat)
  4. Screening for obesity-related comorbidities: laboratory metabolic workup, abdominal ultrasonography (steatohepatitis) and polysomnography findings (obstructive sleep apnea).

The primary outcomes of the study were decrease in BMI Z score, Percentile and body fat at 3 and 6 months of the intervention.

Weight and height was assessed at baseline and monthly for 3-month period and again after 6 month. Body weight and fat percentage was indirectly measured by BIA (Tanita Body-Composition Analyzer, Tanita DC-360 S and GMON Professional Software), which has been clinically verified to be accurate and reliable and to provide highly reproducible results. The GMON software provides the BIA data adjusted for sex, age, height, and race (Caucasian and Asian) according to reference ranges 12The BMI Z score and percentile was calculated using reference data for sex and age. Metabolic parameters documented upon admission included glucose, insulin, HDL, LDL, TG, ALT AST CRP. Fatty liver and fibrosis was assessed by ultrasonography. At each monthly visit the participant provided 3-day dietary questionnaire.

Definition of Study Variables BMI percentiles and Z-scores of anthropometric measurements were calculated with PediTools Electronic Growth Chart Calculators based upon CDC growth charts. The height, weight, and BMI values were converted to sex- and age-specific z-scores according to the CDC 2000 growth charts. Weight status was defined according to the BMI z-score as follows: overweight as a BMI percentile ≥85th and <95th percentiles (1.036 ≤BMI z-score <1.645), and obese as a BMI percentile ≥95th percentile (BMI z-score ≥1.645).

Childhood MetS components were defined as follows: glucose intolerance = fasting glucose ≥100 mg/dL (5.5 mmol/L); elevated BP = systolic and/or diastolic BP ≥90th percentile for sex, age, and height; hypertriglyceridemia = triglyceride (TG) levels ≥110 mg/dL (1.24 mmol/L), and low high-density lipoprotein-cholesterol (HDL-c) = HDL-c ≤40 mg/dL (1.03 mmol/L).

Obesity-related comorbidities were compiled as follows. Insulin resistance was the calculation of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) by fasting insulin μU/mL x fasting glucose mmol/L/22.5. The healthy range for HOMA-IR was defined as a value between 0.5-1.4, early insulin resistance was defined as a value ≥1.9, and significant insulin resistance was defined as a value ≥2.9. Nonalcoholic fatty liver disease (NAFLD) was suspected in a child with typical clinical features (obesity and persistent mild elevations of serum alanine aminotransferase [ALT] >2 x upper limit of normal). A provisional diagnosis of NAFLD was made by excluding other causes of liver disease through a focused history, physical examination, laboratory evaluation, and an abdominal ultrasound showing increased echogenicity suggestive of fatty liver. Obstructive sleep apnea was defined by recurrent events of partial or complete upper airway obstruction during sleep as detected by polysomnography performed in patients with a history of persistent snoring and/or recurrent awakenings. Pseudotumor cerebri was diagnosed according to the modified Dandy criteria: symptoms and signs of increased intracranial pressure (e.g., headache, transient visual obscurations, papilledema, visual loss), no other neurologic abnormalities, elevated intracranial pressure with normal cerebrospinal fluid composition, and a neuroimaging study that shows no etiology for intracranial hypertension .

Statistical Analyses SPSS (IBM Corp. Released 2016. IBM SPSS Statistics for Windows, Version 27.0. Armonk, NY: IBM Corp.) was used for all statistical analysis.

All statistical tests were two-sided. The Kolmogorov-Smirnov test and the Shapiro-Wilk test were applied to assess the normality of continuous data. The data are expressed as means±SDs for normally distributed variables and median and interquartile range [IQR] for skewed distribution. Pearson's chi-square test was performed to compare the distribution of categorical variables between 3 intervention group. Kruskal wallis test followed by Dunn's post hoc test was used to compare the differences between Coffee Tea and placebo for continuous variable . The changes over time were compared for each arm separately using Friedman's test for paired data followed by Dunn's post hoc test. A P value ≤0.05 was considered significant.

Conditions
Body Weight
Being tested
Coffee, Green tea, Herbal tea (placebo)
Keywords
Obesity
Medical subject headings
Body Weight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CoffeeDietary supplement

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

  • 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).

  • 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).

Study groups in NCT05181176
Study groupRoleWhat they receive
CoffeeExperimentalThe 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
Receives: Dietary Supplement: Coffee
Green TeaExperimentalThe 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.
Receives: Dietary Supplement: Green tea
Herbal teaPlacebo comparatorThe 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.
Receives: Dietary Supplement: Herbal tea (placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. effect tea and coffee consumption on body weight

    change in BMI Z score

    Measured: 6 months

Secondary outcomes (1)
  1. effect tea and coffee consumption on body fat

    change in fat percentage analysis using bio electrical impedance analysis

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2022
  2. Study start1 Jan 2021
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion1 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05181176
Sponsor's protocol ID
TLV-18-0166
Status last verified
Dec 2021
First submitted
6 Dec 2021
Last updated
24 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: the individual participant data will be anonymous to other researchers

Publications

  • Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.

    PubMed 24570244
  • Tobias DK, Chen M, Manson JE, Ludwig DS, Willett W, Hu FB. Effect of low-fat diet interventions versus other diet interventions on long-term weight change in adults: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2015 Dec;3(12):968-79. doi: 10.1016/S2213-8587(15)00367-8. Epub 2015 Oct 30.

    PubMed 26527511
  • Wadden TA, Stunkard AJ, Liebschutz J. Three-year follow-up of the treatment of obesity by very low calorie diet, behavior therapy, and their combination. J Consult Clin Psychol. 1988 Dec;56(6):925-8. doi: 10.1037//0022-006x.56.6.925. No abstract available.

    PubMed 3204204
  • Kramer FM, Jeffery RW, Forster JL, Snell MK. Long-term follow-up of behavioral treatment for obesity: patterns of weight regain among men and women. Int J Obes. 1989;13(2):123-36.

    PubMed 2663745
  • Pasman WJ, Westerterp-Plantenga MS, Muls E, Vansant G, van Ree J, Saris WH. The effectiveness of long-term fibre supplementation on weight maintenance in weight-reduced women. Int J Obes Relat Metab Disord. 1997 Jul;21(7):548-55. doi: 10.1038/sj.ijo.0800439.

    PubMed 9226484
  • Mukhtar H, Ahmad N. Tea polyphenols: prevention of cancer and optimizing health. Am J Clin Nutr. 2000 Jun;71(6 Suppl):1698S-702S; discussion 1703S-4S. doi: 10.1093/ajcn/71.6.1698S.

    PubMed 10837321
  • Khan N, Mukhtar H. Tea polyphenols for health promotion. Life Sci. 2007 Jul 26;81(7):519-33. doi: 10.1016/j.lfs.2007.06.011. Epub 2007 Jun 28.

    PubMed 17655876
  • Butt MS, Sultan MT. Green tea: nature's defense against malignancies. Crit Rev Food Sci Nutr. 2009 May;49(5):463-73. doi: 10.1080/10408390802145310.

    PubMed 19399671
  • Nagao T, Hase T, Tokimitsu I. A green tea extract high in catechins reduces body fat and cardiovascular risks in humans. Obesity (Silver Spring). 2007 Jun;15(6):1473-83. doi: 10.1038/oby.2007.176.

    PubMed 17557985
  • Murase T, Nagasawa A, Suzuki J, Hase T, Tokimitsu I. Beneficial effects of tea catechins on diet-induced obesity: stimulation of lipid catabolism in the liver. Int J Obes Relat Metab Disord. 2002 Nov;26(11):1459-64. doi: 10.1038/sj.ijo.0802141.

    PubMed 12439647
  • Zheng G, Sayama K, Okubo T, Juneja LR, Oguni I. Anti-obesity effects of three major components of green tea, catechins, caffeine and theanine, in mice. In Vivo. 2004 Jan-Feb;18(1):55-62.

    PubMed 15011752
  • Lin JK, Lin-Shiau SY. Mechanisms of hypolipidemic and anti-obesity effects of tea and tea polyphenols. Mol Nutr Food Res. 2006 Feb;50(2):211-7. doi: 10.1002/mnfr.200500138.

    PubMed 16404708
  • Auvichayapat P, Prapochanung M, Tunkamnerdthai O, Sripanidkulchai BO, Auvichayapat N, Thinkhamrop B, Kunhasura S, Wongpratoom S, Sinawat S, Hongprapas P. Effectiveness of green tea on weight reduction in obese Thais: A randomized, controlled trial. Physiol Behav. 2008 Feb 27;93(3):486-91. doi: 10.1016/j.physbeh.2007.10.009. Epub 2007 Oct 18.

    PubMed 18006026
  • Westerterp-Plantenga MS, Lejeune MP, Kovacs EM. Body weight loss and weight maintenance in relation to habitual caffeine intake and green tea supplementation. Obes Res. 2005 Jul;13(7):1195-204. doi: 10.1038/oby.2005.142.

    PubMed 16076989
  • Hursel R, Westerterp-Plantenga MS. Green tea catechin plus caffeine supplementation to a high-protein diet has no additional effect on body weight maintenance after weight loss. Am J Clin Nutr. 2009 Mar;89(3):822-30. doi: 10.3945/ajcn.2008.27043. Epub 2009 Jan 28.

    PubMed 19176733

Questions about this trial

What is this clinical trial studying?

A study testing Coffee and Green tea in people with Body Weight, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hadar Moran Lev (00972527360713, hadarlev6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

effect tea and coffee consumption on body weight (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05181176, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.

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