Tokyo, Aug. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058734) titled 'Safety evaluation of excessive intake of dark chocolate' on Aug. 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - EP Mediate Co., Ltd.
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the safety of excessive intake at three times the recommended daily intake of dark chocolate for 4 weeks.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Intake of dark chocolate at three times the recommended daily amount, for 4 weeks
Interventions/Control_2 - Intake of placebo chocolate at three times the recommended daily amount, for 4 weeks
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Males and females aged 20 to 64 years at the time of obtaining consent
2) Ambulatory blood pressure values at the time of the pre-test that meet one of the following criteria:
a) Higher blood pressure (Systolic blood pressure 130-159 mmHg or diastolic blood pressure 85-99 mmHg)
b) Normal blood pressure
3) Subjects who fully understand the purpose and details of the study and voluntarily consent to participate
Key exclusion criteria - 1) Subjects who had exhibited abnormal clinical laboratory values in the past and were judged to be unsuitable for participation in the study
2) Subjects with a current or past medical history of serious diseases such as brain disorders, malignant tumors, immune disorders, kidney disorders, liver disorders, cardiovascular disorders, respiratory disorders, endocrine disorders, or other metabolic disorders
3) Subjects with food allergies
4) Subjects with chronic internal medical conditions requiring continuous treatment (whether topical or oral), those currently undergoing treatment for chronic internal diseases, or those with a history of serious illness requiring medication
5) Subjects with significantly abnormal values deviating from the reference range in physical measurements, physical examinations, or clinical laboratory tests prior to intake
6) Subjects who work in shifts or late at night, and have irregular daily routines or eating habits
7) Subjects who have participated in other clinical studies within one month prior to the start of this study, are currently participating, or wish to participate in such studies during the study period
8) Subjects who plan to become pregnant or breastfeed during the study period
9) Subjects who cannot ingest chocolate daily
10) Subjects who consume foods, beverages, or supplements high in cacao flavanols and cannot discontinue their consumption during the study period
11) Subjects with a current or past medical history of drug or alcohol dependence
12) Heavy alcohol drinkers (average pure alcohol intake of approximately 41 g/day or more)
13) Subjects who plan to travel overseas during the study period
14) Subjects who are judged to be unsuitable based on their responses to the background survey
15) Subjects who are judged unsuitable for the study by the principal investigator for other reasons
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 07 Day
Date of IRB - 2025 Year 08 Month 07 Day
Anticipated trial start date - 2025 Year 09 Month 01 Day
Last follow-up date - 2025 Year 12 Month 10 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067161
Disclaimer: Curated by HT Syndication.
