NCT03537625

Brief Summary

The investigators randomly assigned green tea extract, fermented green tea extract, or placebo in adult subjects whose BMI was 25-35 kg/m2. Participants were 40 in each group, and treatment duration was 12 weeks. Primary outcomes were body weight change and fat mass change from baseline to 12 weeks, and secondary outcomes were metabolic parameteres and gut microbiota.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2016

Status
completed

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 20, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
Last Updated

May 25, 2018

Status Verified

April 1, 2018

Enrollment Period

2.1 years

First QC Date

April 16, 2018

Last Update Submit

May 15, 2018

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • Body weight

    Body weight change were calculated using electronic scale

    Baseline, and 12 weeks

  • Body fat

    Total body fat change were calculated using DXA and abdominal fat CT

    Baseline, and 12 weeks

Secondary Outcomes (4)

  • Waist circumference

    Baseline, 6 weeks, and 12 weeks

  • Lipid profile

    Baseline, and 12 weeks

  • Inflammatory markers

    Baseline, and 12 weeks

  • Microbiota

    Baseline, and 12 weeks

Study Arms (3)

Green tea

EXPERIMENTAL

Green tea extract 2 gram per day

Dietary Supplement: Green tea

Fermented green tea

EXPERIMENTAL

Fermented green tea extract 2 gram per day

Dietary Supplement: Green tea

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Green tea

Interventions

Green teaDIETARY_SUPPLEMENT

We made a dietary supplement from Cammellia sinesis O. Kunze, and made tablets containing extract.

Fermented green teaGreen teaPlacebo

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-60 years
  • BMI 25-35 kg/m2
  • Abdominal obesity (Waist circumference): Male \>90 cm, Female \>85cm

You may not qualify if:

  • Cardiovascular events within 3 months
  • uncontrolled hypertension (\>160/100 mmHg)
  • Diabetes mellitus
  • Dyslipidemia under statin therapy
  • TSH\<0.1 uU/ml or\>10 uU/ml
  • Elevated creatinine level (twice higher than upper normal limit)
  • Elevated AST/ALT level (three times higher than upper normal limit)
  • Pregnancy, lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Interventions

Tea

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

April 16, 2018

First Posted

May 25, 2018

Study Start

March 20, 2016

Primary Completion

April 13, 2018

Study Completion

April 13, 2018

Last Updated

May 25, 2018

Record last verified: 2018-04