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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list