Validation study for anti-metabolic syndrome effect and intestinal functions in healthy Japanese adults: a double-blind randomized controlled trial

Not Applicable

• Conditions: Healthy adults

• Registration Number: JPRN-UMIN000017943
• Lead Sponsor: ORTHOMEDICO, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-17
• Study Completion: 2015-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Currently taking medicines, herbal medicines 4. Taking laver seaweed, sea alga, yogurt, oligosaccharide or lactic acid bacteria more than four times a week. 5. Allergic to medicines or foods related to the test food of this trial 6. Usually taking supplements or nutrient function foods in daily 7. Pregnant, lactating, or planning to get pregnant during the trial period 8. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 9. Judged unsuitable for participating in this trial by physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body fat rate Serum lipid detailed fraction

Secondary Outcome Measures

Name	Time	Method
Intestinal bacterial flora Blood test CAS-MT Bristol stool scale