DRKS00022855Completed未知
Intervention study to investigate effects of VITACEL® extrinsic wheat fibers incorporated in food products for maintenance of normal defecation by increase of fecal bulk in healthy subjects
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Enrollment
- 31
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (—)
- Sex
- All
Inclusion Criteria
- •Subject is in good physical and mental health
- •Average fiber intake = 20 g/ day (during run-in phase)
- •-Stool frequency: 2 - 5 bowel movements per week
- •-BMI between 19.0 and 30.0 kg/m2
- •-Non-smoker
- •-Written consent to participate in the study
- •-Able and willing to follow the study procedures
Exclusion Criteria
- •-Relevant history or presence of any severe medical disorder, potentially interfering with this study in the investigator’s judgement
- •-Subject under prescription for medication or taking dietary supplements possibly interfering with this study within 2 weeks prior to study start or during the study (Stable medication (more than 3 months) for hypertension or thyroid gland is allowed)
- •-Intake of antibiotics in the last 3 months prior to screening
- •-Use of pre- and probiotic supplements
- •-Subjects consuming food or drinks claimed as ‘probiotic’, or ‘prebiotic’ more than once weekly
- •-Subjects consuming food or drinks claimed as ‘rich in fiber’ (including specific milk products) more than 3 times per week
- •-Subjects consuming more than 3 portions of fruits and vegetables (sum) per day
- •-Exclusively vegan or vegetarian diet
- •-Regular laxative use at least once per week
- •-Regular stool consistency of diarrheal subtype at least once every two weeks (Bristol stool scale type 5-7)
- •-Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to cooperate during the study
- •-No availability of a freezer with sufficient capacity to store the provided study foods
- •-Known pregnancy, breastfeeding or intention to become pregnant during the study. A pregnancy test will be conducted during screening and visits 1-4.
- •-Subjects with stool frequency of < 2 stools per week
- •-Known allergy to the test products
- •-Change of dietary habits within the 4 weeks prior to screening
- •-Anticipating any planned changes in lifestyle or physical activity levels for the duration of the study
- •-Subject involved in any clinical or food study within the preceding month
- •-Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Investigators
Similar Trials
Not yet recruiting
Phase 2
To study the Effect of vaitaran basti and panchsam churna in amavata w.s.r. to rheumatoid arthritisCTRI/2020/03/024037Government PG Ayurveda College and HospitalVaranasi
Not yet recruiting
Phase 2
Clinical trial to study the effect of Vimlapana Karma in Varicose UlcerCTRI/2023/06/053968il
Completed
Not Applicable
Management of kidney disease with ayurvedic treatment.CTRI/2022/04/041929J S AYURVED MAHAVIDYALAYA20
Not yet recruiting
Unknown
The study will see how virechan with Haritakyadi Modak treats obesity(sthaulya)CTRI/2024/06/069518RA Podar MedicalAyu College Worli
Not yet recruiting
Unknown
Management of kidney disease with ayurvedic treatment.CTRI/2023/03/050945J S AYURVED MAHAVIDYALAYA