Tokyo, July 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000052122) titled 'Study on the effect of continuous intake of test food on lowing blood pressure' on July 31.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Ezaki Glico Co.Ltd
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Verify the effects of test food on lowing blood pressure
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Test food: Beverage
Intake period: 12 weeks
Daily intake: 160ml
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Subjects whose systolic blood pressure is between 130mmHg and 139 mmHg.
Key exclusion criteria - Subjects who take a medicine or visit the hospital for disease
Subjects who have taken a medicine for disease within 1month from the start of the study excluding headche,menstrual cramps,cold,etc
Subjects who are currently taking antihypertensive medicatins
Subjects who are current past history of serious illness
Subjects who are treatment for dyslipidemia
Subjects who currently taking supplements and health foods that lower blood pressure
Subjects who are current or past history of the digestive system excluding acute appendicitis
Subjects who donated either 400ml whole blood within 3months,200ml whole blood within 1month,prior to this study
Subjects who have severe anemia
Subjects who have food allegie
Pregnant or lactating women or women who expect to be pregnant during this study
Subjects with disorgered lifestyle during this study
Subjects who are currently participate in other clinical trials, or participated
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2023 Year 06 Month 09 Day
Date of IRB - 2023 Year 06 Month 09 Day
Anticipated trial start date - 2023 Year 09 Month 06 Day
Last follow-up date - 2023 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059486
Disclaimer: Curated by HT Syndication.
