UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054117 |
|---|---|
| Receipt number | R000061655 |
| Scientific Title | Acute effects of different dark chocolate intake before resistance exercise on arterial stiffness. |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/10/18 12:08:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Acute effects of different dark chocolate intake before resistance exercise on arterial stiffness.
Acronym
Acute effects of different dark chocolate intake before resistance exercise on arterial stiffness.
Scientific Title
Acute effects of different dark chocolate intake before resistance exercise on arterial stiffness.
Scientific Title:Acronym
Acute effects of different dark chocolate intake before resistance exercise on arterial stiffness.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effect of intake of 0g, 25g and 50g dark chocolate before resistance exercise on arterial stiffness after resistance exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
brachial-ankle pulse wave velocity (baPWV), arterial compliance, beta-stiffness index
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants intake 50g of dark chocolate rich in cocoa polyphenols.
Interventions/Control_2
Participants intake 25g of dark chocolate rich in cocoa polyphenols.
Interventions/Control_3
Participants did not intake dark chocolate.
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Participants who agreed with the study purpose and experimental procedures of this study.
2. Participants who have consented to participate in this study.
3. Participants who have signed an informed consent form.
Key exclusion criteria
1. smoker.
2. obesity (body mass index >30kg/m2).
3. hypertension (systolic blood pressure >=140mmHg, diastolic blood pressure >=90mmHg).
4.diseases or disorders affecting physical activity.
5. pharmacotherapy (including antihyperlipidemic, antihypertensive, or antihyperglycemic medications.(Female only) oral contraceptive).
6. a person with a food allergy.
7. (Female only) not in normal menstrual cycle.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takanobu |
| Middle name | |
| Last name | Okamoto |
Organization
Nippon Sport Science University
Division name
Faculty of sport science
Zip code
158-8508
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
TEL
03-5706-0966
tokamoto@nittai.ac.jp
Public contact
Name of contact person
| 1st name | Urara |
| Middle name | |
| Last name | Hata |
Organization
Nippon Sport Science University
Division name
Graduate School
Zip code
158-8508
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
TEL
090-8182-1026
Homepage URL
23sda11@nittai.ac.jp
Sponsor or person
Institute
Nippon Sport Science University
Institute
Department
Personal name
Funding Source
Organization
Nippon Sport Science University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Sport Science University
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
Tel
03-5706-0931
souspo@nittai.ac.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 | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
11
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
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 11 | Day |
Last modified on
| 2024 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061655
