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Safety evaluation of 12 weeks consumption of indigestible dextrin carbonated beverage in men and women

Safety evaluation of 12 weeks consumption of indigestible dextrin carbonated beverage in men and women - Safety evaluation of 12 weeks consumption of indigestible dextrin carbonated beverage in men and women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021234
Enrollment
10
Registered
2016-02-27
Start date
2016-02-28
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 adult

Interventions

Intake of an indigestible dextrin-containing carbonated beverage 1 bottle per day for 12 weeks.

Sponsors

TTC Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Males and females from 20 to 64 years of age 2) Subjects falling under any of the following A. fasting blood glucose levels are ranged 110 to 125 mg/dL B. 2-hour glucose levels in 75 g OGTT are ranged 140 to 199 mg/dL

Exclusion criteria

Exclusion criteria: 1) Subjects having a disease requiring treatment or a history of serious diseases, diabetes, hepatopathy, renal or heart disease 2) Subjects having possibilities for emerging allergy related to the study 3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required 4) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 5) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 6) Subjects who intend to become pregnant or lactating 7) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 8) Subjects judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Hematologic test Blood biochemistry test Urine analysis Blood pressure/pulsation Weight/ body mass index Doctor's questions Adverse event Evaluate at points of 4-week, 8-week and 12-week consumption and 4 weeks after the end of consumption period.

Countries

Japan

Contacts

Public ContactMika Watanabe

TTC Co.,Ltd. Clinical Research Planning Department

m.watanabe@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

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