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Energy value confirmation study of the dietary fiber material using breath measurement

Energy value confirmation study of the dietary fiber material using breath measurement - Energy value confirmation study of the dietary fiber material using breath measurement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030873
Enrollment
32
Registered
2018-01-18
Start date
2018-01-19
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

High cross-linked tapioca resistant starch 5g of resistant starch, single intake high cross-linked potato resistant starch 5g of resistant starch, single intake Fruct-oligosaccharide 5g of FOS, si

Sponsors

Ingredion Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Those whose BMI is 18 or more and less than 25 (2) Normal Blood sugar value (3) Those who are informed to the fullest extent about the purposes and contents of the study, have the ability to give consent, volunteer for participation after having fully understood, and agree to participate in the study writing.

Exclusion criteria

Exclusion criteria: (1)Those who have relatives within the fourth degree with diabetes (2)Those who have extremely high methane in the breath or those have little hydrogen as a result of the breath test of the screening test (3)Those who cannot quit ingesting foods with high hydrogen discharge, such as yogurt or sugar alcohol, and foods enhanced with oligosaccharides and dietary fiber during the study (see Attachments 1 and 2) (4)Those who have chronic disease and regularly use medicines (5)Those who regularly consume excessive alcohol and tobacco (6)Those who have disease that is considered to affect gastric emptying (7)Those who have heavy constipation (8)Those who have gastrointestinal disease affecting digestion and absorption and who have a surgical history of the digestive organs (9)Those with a diagnosis of IBS (irritable bowel syndrome) (10)Those who have a disease such as upper respiratory inflammation and acute gastroenteritis (11)Those who were determined unsuitable as subjects from the blood test conducted for the screening test (12)Those who provided sampling blood or donated ingredient blood that was more than 200 mL within one month preceding the date of informed consent or more than 400 mL within three months preceding the date of informed consent (13)Those who have a past medical history or a current medical history of drug dependence or alcohol dependence (14)Those who are participating in or are willing to participate in the study in which other foods are ingested or medicines are used or the study applying cosmetics and medicines (15)Those who are pregnant, those who intend to become pregnant during the study, those who are breastfeeding (16)In addition, those who were determined to be inappropriate as subjects by the investigator

Design outcomes

Primary

MeasureTime frame
Change over time of the breath hydrogen Cmax of the breath hydrogen, AUC

Secondary

MeasureTime frame
Interview, blood pressure/ pulse rate, subjective and objective symptom, adverse events

Countries

Japan

Contacts

Public ContactKenichi Matsushima

Ingredion Japan K.K. Food Technical Service

knenichi.matsushima@ingredion.com(03)3504-9914

Outcome results

None listed

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