Unique ID issued by UMIN | UMIN000050105 |
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Receipt number | R000057072 |
Scientific Title | Effects of Trigonelline Intake on Cognitive Function in Middle-Aged and Older Adults: A 12-Week Randomized Controlled Trial |
Date of disclosure of the study information | 2023/12/31 |
Last modified on | 2023/07/17 15:37:59 |
Effects of Trigonelline Intake on Cognitive Function in Middle-Aged and Older Adults: A 12-Week Randomized Controlled Trial
Effects of Trigonelline Intake on Cognitive Function
Effects of Trigonelline Intake on Cognitive Function in Middle-Aged and Older Adults: A 12-Week Randomized Controlled Trial
Effects of Trigonelline Intake on Cognitive Function
Japan |
Healthy subjects
Not applicable | Adult |
Others
NO
The purpose of the study is to elucidate the effects on cognitive function of daily trigonelline ingestion for 12 weeks in middle-aged and older adults by a randomized controlled trial. The primary outcome is cognitive function, and secondary outcome measures are blood biomarkers (amyloid-beta and brain-derived neurotrophic factor (BDNF)).
Efficacy
Confirmatory
Explanatory
Not applicable
Cognitrax
Blood Concentration of Amyloid1-40
Blood Concentration of Amyloid1-42
Brain-derived neurotrophic factor
"Trail making peg" test
Geriatric Depression Scale
Pittsburgh Sleep Quality Index
Profile of Mood States 2nd Edition
Physical Activity Scale for the Elderly
SF8 Health Survey
Body composition measured by bioelectrical impedance analysis
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
3
Prevention
Food |
Trigonelline low-dose group for 12 weeks
Trigonelline high-does group for 12 weeks
Placebo group for 12 weeks
55 | years-old | <= |
89 | years-old | >= |
Male and Female
(1) Persons between the ages of 55 and 89 at the time the consent form is obtained.
2) Those who do not have a history of diabetes, cerebrovascular disease, cardiovascular disease, cancer, or paralysis
(iii) Those who can drink coffee beverages (no allergies or rejection)
(iv) Those who are able to discontinue the consumption of Sakurajima radish, hemp seed, oats, fenugreek, and shiso juice during the period of this study.
(5) Those who are able to avoid eating potatoes, peas, perilla leaves, sea urchin, and jellyfish as much as possible during the period of this study. In addition, the subjects must be able to keep the upper limit of coffee intake other than that provided as the test food: 1 cup (200 ml) per day.
(5) Those who have not participated or are not currently participating in any other clinical research within the past 3 months.
(6) Those who fully understand the content of this study and are able to commute to the study site on their own.
Subjects with dementia (MMSE<-23 points) and depressions (GDS>-11 points).
And/or are taking these medications
90
1st name | Tomohiro |
Middle name | |
Last name | Okura |
University of Tsukuba
Faculty of Health and sport science
305-8574
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
+81-29-853-2733
okura.tomohiro.gp@u.tsukuba.ac.jp
1st name | Tomohiro |
Middle name | |
Last name | Okura |
University of Tsukuba
Faculty of Health and sport science
305-8574
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
+81-29-853-2733
okura.tomohiro.gp@u.tsukuba.ac.jp
University of Tsukuba
N.A.
Profit organization
Japan
University of Tsukuba, Faculty of Health and sport science, Research Ethics Committee
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
+81-029-853-2571
tg-kenkyurinri@un.tsukuba.ac.jp
NO
2023 | Year | 12 | Month | 31 | Day |
Unpublished
No longer recruiting
2023 | Year | 01 | Month | 23 | Day |
2022 | Year | 12 | Month | 28 | Day |
2023 | Year | 01 | Month | 23 | Day |
2023 | Year | 05 | Month | 31 | Day |
2023 | Year | 06 | Month | 30 | Day |
2023 | Year | 09 | Month | 30 | Day |
2023 | Year | 12 | Month | 31 | Day |
2023 | Year | 01 | Month | 23 | Day |
2023 | Year | 07 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057072
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