Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/11/2014
Date assigned
10/12/2014
Last edited
10/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Catechins in tea and chlorogenic acids in coffee are chemicals called polyphenols that can help people maintain a healthy weight by increasing metabolism (the rate in which the body uses energy) but the effect varies between people. The aim of this study is to identify novel biomarkers which give information about a persons metabolic rate (metabolic status) after consumption of these polyphenols.

Who can participate?
Healthy male volunteers aged 20 to 59 years who are normal weight or overweight (body mass index 18.5-29.9 kg/m2).

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given coffee (which contains chlorogenic acids) to drink every day for 4 weeks. Those in group 2 are given green tea (which contains catechins) to drink every day for 4 weeks. Urine and blood samples are collected before and after drinking the tea or coffee with a cookie. After a break of two weeks or more, all participants repeat this process with a placebo (dummy) drink.

What are the possible benefits and risks of participating?
Participants will find out about how they react to the polyphenols and whether they could improve their metabolism by taking them. Risks of participating may include pain and, in some cases, internal bleeding during blood sampling.

Where is the study run from?
Tochigi Research Laboratories (Japan).

When is the study starting and how long is it expected to run for?
February 2014 to July 2014.

Who is funding the study?
Kao Corporation (Japan).

Who is the main contact?
Dr Akira Shimotoyodome

Trial website

Contact information

Type

Scientific

Primary contact

Dr Akira Shimotoyodome

ORCID ID

Contact details

2606 Akabane
Ichikai-Machi
Haga-Gun
Tochigi
321-3497
Japan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

507-131203

Study information

Scientific title

Metabolite Identification after Polyphenol Ingestion in Adults: a randomized double-blind placebo-controlled crossover study

Acronym

MIPIA

Study hypothesis

Dietary supplementation with tea catechins and coffee chlorogenic acids enhanced energy metabolism in humans. The aim of this study is to identify novel biomarkers in urine and blood which reflect metabolic status after consumption of dietary polyphenols in Japanese male adults.

Ethics approval

Human Research Ethics Committee of Biological Science Laboratories of Kao Corporation, 19/12/2013, ref: 507-20131218

Study design

Randomized double-blind placebo-controlled crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Urine and blood biomarkers after consumption of dietary polyphenols

Intervention

Twenty subjects were randomized into either the coffee group or the green tea group (10 for each group). They ingested a test beverage including either 390 mg chlorogenic acids for the coffee group or 646 mg catechins for the green tea group per day for 4 weeks. At the time before and after the intervention period, indirect calorimetry was performed, and urine and blood samples were collected before and after ingestion of the test beverage with a cookie meal. Subjects ingested the test (coffee or green tea) and placebo beverages. There was the washout period of two weeks or more between the intervention period of the test and placebo beverages.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Metabolomic profiles of urine and blood which associate with indirect calorimetry; Timepoints: baseline (before intervention period), after 4-week intervention period, fasting and postprandial states

Secondary outcome measures

Metabolomic profiles of urine and blood which associate with the polyphenol intake; Timepoints: baseline (before intervention period), after 4-week intervention period, fasting and postprandial states

Overall trial start date

07/02/2014

Overall trial end date

10/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy volunteers aged 20 to 59 years
2. Male
3. Normal weight or overweight (body mass index 18.5-29.9 kg/m2)

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

20

Participant exclusion criteria

1. Caffeine intoxication
2. Food allergy
3. Intake of catechins or chlorogenic acid supplements
4. Serious illness (such as heart disease, kidney disease, diabetes and so on)

Recruitment start date

07/02/2014

Recruitment end date

10/07/2014

Locations

Countries of recruitment

Japan

Trial participating centre

Tochigi Research Laboratories
2606 Akabane Ichikai-Machi Haga-Gun
Tochigi
321-3497
Japan

Sponsor information

Organisation

Kao Corporation (Japan)

Sponsor details

14-10
Nihonbashi Kayabacho 1-chome
Chuo-ku
Tokyo
103-8210
Japan

Sponsor type

Industry

Website

http://www.kao.com/jp/

Funders

Funder type

Industry

Funder name

Kao Corporation (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes