Intervention trial by regular exercise and broccoli supplement against age-related cognitive decline

JRCT ID: jRCTs021190008

Registered date:09/09/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Cognitive decline with aging
• Date of first enrollment: 26/09/2019
• Target sample size: 60
• Study type: Interventional

Intervention(s)

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

Outcome(s)

Primary Outcome

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.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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.

Related Information

• Primary Sponsor: Itoh Ken
• Secondary Sponsor: Nature & wellness research department, innovation division, KAGOME CO., LTD