Tokyo, Aug. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058456) titled 'A study of the effect of continuous consumption of olive fruit extract on post-exercise fatigue' on Aug. 22.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - others
Condition:
Condition - Healthy subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effects of one week of continuous consumption of the test food on post-exercise fatigue in Japanese men and women between the ages of 30 and 65.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of active food-Washout period-Intake of placebo food
Interventions/Control_2 - Intake of placebo food-Washout period-Intake of active food
Eligibility:
Age-lower limit - 30
years-old
Gender - Male and Female
Key inclusion criteria - 1.Japanese men and women between 30 and 65 years of age at the time of obtaining written informed consent.
2.Subjects who are not in the habit of exercising (not meeting the following definition)
*Subjects who have been exercising at least twice a week for at least 30 minutes each time for one year.
3.Subjects who have been fully explained the purpose and contents of the study ,are capable of consenting, fully understand the content ,and voluntarily volunteer to participate in the study and agree to participate in the study in writing.
Key exclusion criteria - 1.Subjects who are taking medication or under medical treatment.
2.Subjects who are under exercise therapy or dietetic therapy.
3.Subjects who have developed allergies as for the foods test.
4.Subjects with current or history of drug dependence or alcohol dependence.
5.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past.
6.Subjects with smoking habit.(Have smoked within the last year.)
7.Subjects with irregular life rhythms due to night shifts or shift work.
8.Subjects with heavy alcohol consumption.(Subjects whose average daily net alcohol intake exceeds approximately 60g)
9.Subjects with extremely irregular lifestyle habits such as eating and sleeping.
10.Subjects who have an extremely unbalanced diet.
11.Subjects with serious current or previous illnesses such as brain disease, malignancy, immunological disease, diabetes, liver disease (hepatitis),renal disease, cardiac disease, thyroid disease, adrenal gland disease, tendon disease, joint contracture, orthopedic disease, or other metabolic diseases.
12.Subjects who have suffered a serious injury to the locomotor organs such as fracture, tendon rupture, or flesh tear within the past year, or who have difficulty performing exercise load due to pain or discomfort in the locomotor organs.
13.Subjects using health foods, supplements, and medications that reduce fatigue.
14.Subjects who have participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period.
15.Subjects who have collected 200mL of blood or donated more than 400mL of blood within 3months from the date of consent acquisition.
16.Subjects who are planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
Target Size - 32
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 05 Month 30 Day
Date of IRB - 2025 Year 06 Month 13 Day
Anticipated trial start date - 2025 Year 08 Month 18 Day
Last follow-up date - 2025 Year 11 Month 21 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066776
Disclaimer: Curated by HT Syndication.
