A study to evaluate the optimal dose of FenuLife® (water soluble fiber) for assessment of its effect on occasional burning sensation and associated complaints
- Conditions
- 1) Occasional burning sensation2) Upper abdomen discomfort3) Regurgitation4) Stomach fullness
- Registration Number
- DRKS00027126
- Lead Sponsor
- Frutarom Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
1. 18-60 years of age
2. Body Mass Index (BMI) 18.5-34.9 kg/m²
3. Generally healthy, as judged by the investigator at V1,
based on self-reported medical history and physical examination
4. Occasional epigastric burning sensation after meals (selfreported)
within at least one month prior to V1
5. A sufficient burning sensation intensity after the provocative
standardized meal at V1 (>20mm at a 100-mm visual
analogue scale (VAS), and lasting burning sensation until
the end of the hour after the meal (>15 mm on a 100-mm
VAS)
6. Willingness to comply with the study requirements, in particular:
- consume the provocative meal at visits
- complete the study assessments at visits
7. Willingness not to change dietary habits (no start/change
of diet) and general life-style (e.g. level of physical activity)
during study duration
8. Willingness not to use antacids or any products against
burning sensation in the 12 hours prior to and during any
visit
9. Willingness not to use proton-pump inhibitors, H2 receptor
antagonists (H2RA) or any products against epigastric
burning sensation (besides antacids) during the study
10. Females of child-bearing potential: willingness to use appropriate
contraception methods during the study; negative
pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
1. Self-reported known allergies or hypersensitivity to any of
the test components or the standardized provocative meal
2. Self-reported known diseases that may indirectly affect digestion,
confound study results or interfere with compliance, as per investigator’s judgment (e.g. diabetes,
biliary tract disease, ulcer, irritable bowel disease)
3. Self-reported known diagnosis of gastroesophageal reflux
disease (GERD)
4. Involuntary loss of weight within 3 months prior to V1
5. History of foregut surgery
6. Smoking
7. Regular use of treatment that may indirectly affect digestion,
confound study results or interfere with compliance,
as per investigator’s judgment (e.g. antibiotics, osteoporosis
drugs, non-steroidal anti-inflammatory drugs, prokinetics)
8. Use of any dietary supplements for reducing burning sensation
/natural fibres additives within 1 month prior to V1
9. Use of any products against epigastric burning sensation
(except antacids) within 2 weeks prior to V1
10. Females who are pregnant or breast-feeding
11. Abuse of drugs, alcohol or medication within 6 months
prior to V1 and/or during the study
12. Participation in any clinical trial within 3 months prior to V1
or during the study
13. Other reasons judged by the investigator to render the
subject unsuitable for the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in 6-point Likert scale assessment of overall intensity of burning sensation<br>retrospectively for the entire duration of 3 hours post meal.
- Secondary Outcome Measures
Name Time Method - Differences in 6-point Likert scale assessment of overall intensity of associated<br>complaints as well as stomach fullness (assessed for each condition separately)<br>retrospectively for the entire duration of 3 hours post meal<br>- Differences in VAS assessment of intensity of burning sensation and associated<br>complaints as well as stomach fullness (maximal value, total/incremental<br>AUC) (assessed for each condition separately)<br>- Differences in time to onset of burning sensation and associated complaints as<br>well as stomach fullness (time point of end of meal subtracted from time point<br>of start of first signs) (assessed for each condition separately)<br>- Differences in duration of burning sensation and associated complaints as well<br>as stomach fullness (time point of start of condition subtracted from time point<br>of end of condition) (assessed for each condition separately)<br>- Differences in global evaluation of satisfaction concerning the applied intervention<br>by the subject