Metabolite Identification after Polyphenol Ingestion in Adults
| ISRCTN | ISRCTN15516017 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15516017 |
| Secondary identifying numbers | 507-131203 |
- Submission date
- 05/11/2014
- Registration date
- 10/12/2014
- Last edited
- 20/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
2606 Akabane
Ichikai-Machi
Haga-Gun
Tochigi
321-3497
Japan
Study information
| Study design | Randomized double-blind placebo-controlled crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Scientific title | Metabolite Identification after Polyphenol Ingestion in Adults: a randomized double-blind placebo-controlled crossover study |
| Study acronym | MIPIA |
| Study objectives | 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(s) | Human Research Ethics Committee of Biological Science Laboratories of Kao Corporation, 19/12/2013, ref: 507-20131218 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 07/02/2014 |
| Completion date | 10/07/2014 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 20 |
| Key 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) |
| Key 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) |
| Date of first enrolment | 07/02/2014 |
| Date of final enrolment | 10/07/2014 |
Locations
Countries of recruitment
- Japan
Study participating centre
Ichikai-Machi
Haga-Gun
Tochigi
321-3497
Japan
Sponsor information
Industry
14-10
Nihonbashi Kayabacho 1-chome
Chuo-ku
Tokyo
103-8210
Japan
| Website | http://www.kao.com/jp/ |
|---|---|
"ROR" |
https://ror.org/016t1kc57 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2016 | Yes | No | |
| Results article | results | 07/03/2019 | Yes | No |
Editorial Notes
20/02/2019: Publication references added.
