Randomized control trial for functional nozawana processed food to improve defecation and body fat percentage

Phase 2

• Conditions: A healthy male and female between 20 and 64 years old with a BMI of 25 or more and less than 30

• Registration Number: JPRN-UMIN000039215
• Lead Sponsor: ational Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-22
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Persons who regularly eat medicines, functional display foods, foods for specified health use, health foods, etc., which are likely to affect the test results (2) Those currently on a diet or planning to diet (3) Those who eat more than 200 g of Nozawana pickles a day (4) Heavy alcohol drinkers (5) Persons with extremely irregular eating habits, those with irregular life rhythms (6) Persons who have a severe current medical history in the heart, liver, kidney and digestive organs (7) Those pregnant or planning pregnancy, and those who are breastfeeding (8) Persons who are allergic to pharmaceuticals and foods (in particular Nozawana product) (9) Those who donated blood donated from the previous month or started donating 200 mL of whole blood (10) A man who donated 400 mL of whole blood three months before the start of the test (11) Women who donated 400 mL of whole blood from 4 months before the start of the test (12) A man who may donate more than 1,200 mL of whole blood from 12 months plus total blood draw amount of this test. (13) Women who may donate more than 800 mL of whole blood from 12 months plus total blood draw amount of this test. (14) Person who judged that participation in the examination is inappropriate by the investigator (medical doctor) or exam sharing physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in body fat percentage after intervention

Secondary Outcome Measures

Name	Time	Method
Change in serum lipid level, body weight, BMI, Intestinal flora, stool frequency / week and shape