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Integrative aging control intervention trial for age-related cognitive decline (Anti-aging trial)

Intervention trial by regular exercise and broccoli supplement against age-related cognitive decline (Anti-aging trial)

28

1) Control food group >Gender: 8 males and 4 females >Median age (min-max): 78 (66-90) years 2) Test food group >Gender: 9 males and 4 females >Median age (min-max): 63 (46-70) years

>Assessed for eligibility: 28 subjects. >Randomized: 26 subjects. Allocation of 13 participants in each group to the active or placebo group After allocation, 1 person dropped out of the active group at the pre-intervention stage. >Study completed: 10 in the active group and 9 in the placebo group.

1) Unexpected adverse events and undeniably related to the test food Three transient, mild, non-serious events (constipation, heartburn, lethargy) occurred but all recovered. (2) Serious adverse events, which were judged to have no causal relationship to the study One each of colorectal polyps, cerebral haemorrhage, heart failure, urinary tract infection and gastric cancer occurred.

1) Primary endpoint. The median change in MPI scores from baseline to the end of the intervention was +3.6 (IQR 9.6) and +13.4 (IQR 11.5) for the placebo and active groups, respectively, confirming that the active group exceeded the reference point of 5 points and the placebo group, but the Mann-Whiteney U-test showed only a significant trend, p = 0.079. Therefore, it could not be concluded from the results of this study alone that the test food was effective against age-related cognitive decline, but it was found that future studies may demonstrate its effectiveness. 2) Secondary endpoint >Multivariate analysis of change in MPI score over time To assess the effect of the intervention over the entire study period (measurement points: 0, 3, 6, 18, 30 and 42 months), a multiple regression analysis was conducted with the objective variable being the change in MPI score, the explanatory variable being the group and the adjustment factor being the measurement point (0, 3, 6, 18, 30 and 42 months). MPI score variability of the active group significantly exceeded that of the placebo group (p = 0.047). Therefore, similar to the primary outcome results, it was found that future studies may show that the test food is effective against age-related cognitive decline. >MCI conversion rate, MCI to dementia conversion rate. The results of the chi-square test showed no significant differences in the conversion rates between the placebo and active groups at both 18 and 42 months after the start of the study. The results of this study alone could not be used to assess the effect of the test food due to the small number of cases. >Compliance The mean intake rate +/- SD per group was 94.3 +/- 1.9% for the control food intake group and 95.4 +/- 2.9% for the test food intake group, with high intake rates in both groups and no statistically significant differences in values between the two groups. >Urinary sulforaphane glucosinolate metabolites (corrected for urinary creatinine concentration) Urinary sulforaphane glucosinolate metabolites were significantly higher in the active group than in the placebo group at 18 months post-test (Mann-Whiteney U test, p = 0.004). The results of the chi-square test showed no significant differences in the conversion rates between the placebo and active groups at both 18 and 42 months after the start of the study. The results of this study alone could not be used to assess the effect of the test food due to the small number of cases. >Compliance The mean intake rate +/- SD per group was 94.3 +/- 1.9% for the control food intake group and 95.4 +/- 2.9% for the test food intake group, with high intake rates in both groups and no statistically significant differences in values between the two groups. >Urinary sulforaphane glucosinolate metabolites (corrected for urinary creatinine concentration) Urinary sulforaphane glucosinolate metabolites were significantly higher in the active group than in the placebo group at 18 months post-test (Mann-Whiteney U test, p = 0.004).

The results of this study did not allow for the conclusion that the intake of the test food was effective against age-related cognitive decline. On the other hand, a trend towards maintaining cognitive function in the subjects was observed, indicating that future studies may demonstrate the efficacy of the test food. In addition, the intake rate of the supplements exceeded 90%, indicating that the study was valid.

Jan. 31, 2026

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs021190008

Itoh Ken

Hirosaki University Graduate School of Medicine

5 ZAIFU-CHO, HIROSAKI, AOMORI

itohk@hirosaki-u.ac.jp

Itoh Ken

Hirosaki University Graduate School of Medicine

5 ZAIFU-CHO, HIROSAKI, AOMORI

+81-172-39-5158

itohk@hirosaki-u.ac.jp

Complete

Aug. 26, 2019

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

Those who fell under the following screening criteria and are suspected of having memory impairment in the memory examination of the Iwaki Health Promotion Project Medical Checkup in 2014-2017. Some of the above were susequently diagnosed as having mild cognitive impairment by the detailed health checkup in Univeristy hospital.

-Screening criteria-
Subjects who satisfied all following 1-3 criteria
1. cognitive dysfunction recognized by both the subject or its family
2. delay playback score are less than 2 points in MMSE problem 5
3. WMS-R Logical Memory Test II meets the following criteria
/8 points or less for the subject with 16 years of education/ 4 points or less for the subject with 10-15 years of education/ 2 points or less for the subject 9 years or less

1. Those who suffer from severe lovel of cancer, diabetes, high blood pressure or etc.
2. Those who are taking cholin esterase inhibitors (only for the treatment of dementia)
3. Those who are allergic to the ingredients contained in the test supplement
4. Those who suffer from psychosis or express psychiatric symptoms
5. Those who suffer from dementia.

Both

Cognitive decline with aging

arm 1: three broccoli-based supplemet taken daily for 3.5 years
arm 2: three placebo capsules daily for 3.5 years

both arm1 and 2: exercise intervention once a week for the first six months, every tow months for the next 3 years

cognitive decline

1, Transiton of Memory performance index score from the start of the test to the end (three months, six months, 1.5 years, 2.5 years and 3.5 years after the start of the test).
2. Change of memory performance index score on 3.5 years after the start of the test.

1) Change of memory performance index score on three months, six months, 1.5 years, 2.5 years and 3.5 years after the start of the test.
2) The following items at 1.5 years and 3.5 years after the start of the test.
1. Convertion rate from MCI to dementia
2. Revertion rate from MCI to normal state
3. Convertion rate from nomal state to MCI
4. Questionnaire (concurrent supplement name, intake status of broccoli sprout)
5. Clinical findings at diagnosis of MCI and dementia
6. Physical function (grip strength)
7. Aging index (weight, BMI, blood pressure)
8. Urinary sulforaphane glucosinolate metabolites concentration

+81-172-39-5362

Aug. 21, 2019

none