1) Occasional burning sensation 2) Upper abdomen discomfort 3) Regurgitation 4) Stomach fullness
Conditions
Interventions
Group 1: Intervention arm Dosage 1 (D1) group will receive 0.75 g FenuLife® (all subjects)
Group 2: Intervention arm Dosage 2 (D2) group will receive 1.0 g FenuLife® (all subjects)
Group 3: Interventi
0 g FenuLife® (all subjects)
Sponsors
Frutarom Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in 6-point Likert scale assessment of overall intensity of burning sensation retrospectively for the entire duration of 3 hours post meal. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Differences in 6-point Likert scale assessment of overall intensity of associated complaints as well as stomach fullness (assessed for each condition separately) retrospectively for the entire duration of 3 hours post meal - Differences in VAS assessment of intensity of burning sensation and associated complaints as well as stomach fullness (maximal value, total/incremental AUC) (assessed for each condition separately) - Differences in time to onset of burning sensation and associated complaints as well as stomach fullness (time point of end of meal subtracted from time point of start of first signs) (assessed for each condition separately) - Differences in duration of burning sensation and associated complaints as well as stomach fullness (time point of start of condition subtracted from time point of end of condition) (assessed for each condition separately) - Differences in global evaluation of satisfaction concerning the applied intervention by the subject | — |
Countries
Germany
Contacts
Public ContactLiana Vismane
Studienzentrum analyze & realize GmbH
Outcome results
None listed