UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052400 |
|---|---|
| Receipt number | R000059819 |
| Scientific Title | Placebo-controlled, randomized trial to evaluate the intestinal environments by the continuous supplementation of apple polyphenols |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2023/10/04 10:03:44 |
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Basic information
Public title
Placebo-controlled, randomized trial to evaluate the intestinal environments by the continuous supplementation of apple polyphenols
Acronym
Evaluation of the intestinal environments by the continuous supplementation of apple polyphenols
Scientific Title
Placebo-controlled, randomized trial to evaluate the intestinal environments by the continuous supplementation of apple polyphenols
Scientific Title:Acronym
Evaluation of the intestinal environments by the continuous supplementation of apple polyphenols
Region
| Japan |
Condition
Condition
Japanese between 40 and 65 years old with a BMI between 18.5 kg/m2 and 30.0 kg/m2
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of intake apple polyphenols, such as procyanidins, on the intestinal environment, including the gut microbiota and metabolites, in a human clinical trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota in feces, metabolites in urine
Key secondary outcomes
Physical measurements (height, weight, BMI, visceral fat area), blood tests (TC, LDL-C, HDL-C, TG, total bile acid, fasting blood glucose, HbA1c, insulin, (AST, ALT, gamma-GTP, ALP, LDH, 1.5-AG, total bile acid, CRP), dietary habits questionnaire (health food intake , diet and exercise habits, drinking and smoking habits, sleep duration)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Apple polyphenol (600 mg) 3 capsules
Interventions/Control_2
Purified agar (600 mg) 3 capsules
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | < |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Subjects who fully understand the significance, content, and purpose of this study and have given written consent to participate in this study.
(2) Japanese men and women between the ages of 40 and 65 years
(3) BMI between 18.5 kg/m2 and 30.0 kg/m2
Key exclusion criteria
(1)Those who regularly take supplements that contain ingredients that may affect the results of this study
(2) Those who are participating in other clinical trials at the start of this study
(3) Who have ever complained of physical discomfort due to ingestion of apples or polyphenols
(4) Patients with a history of heart failure or myocardial infarction
(5) Excluded due to diseases
(6) Those suffering from serious cerebrovascular disease, cardiac disease, liver disease, renal disease, gastrointestinal disease, or infectious disease requiring notification.
(7) Those who have a history of major surgery on the digestive system, such as gastrectomy, gastrointestinal suture, or intestinal resection
(8) Those with significant abnormalities in physical measurements, blood pressure measurements, or blood tests
(9) Those with a low hemoglobin level
(10) Women around menopause who show significant changes in their physical condition
(11) Persons who may show allergic symptoms to drugs or foods
(12) Excessive smokers: smokers who generally smoke 21 or more cigarettes per day
(13) Regular users of alcohol: Those who generally drink more than 20 g of pure alcohol per day
(14) Those whose lifestyle is extremely irregular: frequently skip two or more meals, eat out for dinner almost every day, work night shifts, or do not regularly take days off
(15) Women who have donated 400 mL blood within 16 weeks prior to the start of intake, men who have donated 400 mL blood within 12 weeks prior to the start of intake, and those who have donated 200 mL blood within 4 weeks or component blood within 2 weeks prior to the start of intake
(16) Women who are pregnant or possibly pregnant, or lactating
(17) Any participant in any other clinical trial, observational study, clinical trial, or home use test between 4 weeks prior to the start of the study period and the end of the intake period
(18) Any other person deemed ineligible by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Shoji |
Organization
Food Research Institute, National Agriculture and Food Research Organization
Division name
Division of Food Function Research
Zip code
305-8605
Address
2-1-12, Kannondai, Tsukuba, Ibaraki
TEL
029-838-8041
tshoji@affrc.go.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Shoji |
Organization
Food Research Institute, National Agriculture and Food Research Organization
Division name
Division of Food Function Research
Zip code
305-8605
Address
2-1-12, Kannondai, Tsukuba, Ibaraki
TEL
029-838-8041
Homepage URL
tshoji@affrc.go.jp
Sponsor or person
Institute
Food Research Institute, National Agriculture and Food Research Organization
Institute
Department
Personal name
Funding Source
Organization
Aomori Apple Council Incorporated Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
HIrosaki city hall
Hirosaki University
Fukushima University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Agriculture and Food Research Organization
Address
2-1-12, Kannondai, Tsukuba, Ibaraki
Tel
029-838-6933
kogaban@nano.affrc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
68
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059819
