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Intestinal Regulation and Physical Composition Evaluation Trial by Continued Consumption of Test Beverage

Intestinal Regulation and Physical Composition Evaluation Trial by Continued Consumption of Test Beverage - A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study - - Intestinal Regulation and Physical Composition Evaluation Trial by Continued Consumption of Test Beverage - A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study -

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054456
Enrollment
80
Registered
2024-05-23
Start date
2024-08-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Participants intake test beverage of 280mL daily for eight weeks. Participants intake placebo beverage of 280mL daily for eight weeks.

Sponsors

IMEQRD Co. Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age: 20 to less than 65 years old at time of informed consent 2.Sex: Japanese men and women 3.BMI of 22 to less than 30 kg/m^2 4.Constipation tendency (four bowel movements per week or fewer than four bowel movements per week) 5.Capable to enter digital diary via smartphone or PC. 6.Voluntarily agrees to participate after understanding the purpose and content of the research, and provides written consent.

Exclusion criteria

Exclusion criteria: 1.Currently undergoing treatment for any disease, or taking medication or herbal remedies (as-needed medication allowed) 2.Undergoing diet or exercise therapy under medical supervision 3.Planning to undergo endoscopy or gastric barium testing during study period. 4.Has metal in the CT measurement area. 5.Has an implantable cardioverter-defibrillator such as a pacemaker. 6.Has been diagnosed with familial hyperlipidemia. 7.Has or had a drug addiction. 8.Has history of serious liver, kidney, heart, respiratory, endocrine, metabolic disease (such as diabetes). 9.Has undergone gastrointestinal surgery (except appendicitis). 10.Is lactose intolerant or has been diagnosed with lactose intolerance. 11.Has current or previous drug or food allergy. 12.Currently taking over-the-counter drugs, quasi-drugs, special health foods for health maintenance or recovery, foods for specified health uses, health foods, supplements, and can't stop intake during the research period. 13.Regularly consumes foods or supplements containing many lactic acid bacteria, Bifidobacterium, oligosaccharides, dietary fiber (four times a week or more as a guide). 14.Has irregular lifestyle (shift work, night work etc.) 15.Plans to travel abroad during study period. 16.Heavy smoker (21 or more cigarettes per day). 17.Heavy drinker (intake of pure alcohol 40g/day or more). 18.Currently pregnant or nursing or planning to become pregnant during the study period. 19.Has participated in other clinical studies in the month before consent acquisition or currently participating, or plans to participate during the research period. 20.Experienced major changes in lifestyle habits (eating, sleeping, exercise habits, etc.) or social environment (moving, job loss, divorce, death of a spouse or relative, etc.) within a month before consent acquisition. 21.Deemed unsuitable to participate in this study by the Principal Investigator.

Design outcomes

Primary

MeasureTime frame
-Number of Bowel Movements -Days of Bowel Movement -Amount of Bowel Movement

Secondary

MeasureTime frame
-Stool Condition -Defecation Survey -Evaluation of Intestinal Flora (16S rRNA Gene Analysis) -Intra-abdominal Fat Area, Subcutaneous Fat Area, Total Fat Area by CT -Waist Circumference, Hip Circumference, Waist-to-Hip Ratio -BMI -Body Fat Percentage -Body Weight

Countries

Japan

Contacts

Public ContactHirokuni Kayama

IMEQRD Co., Ltd. Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026