Dose-escalation study to evaluate safety and gastrointestinal tolerability of allulose in subjects compared to placebo
- Conditions
- Healthy subjects
- Registration Number
- DRKS00017848
- Lead Sponsor
- Pfeifer & Langen GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 49
Subjects of both genders, who will be included, must fulfil all the following criteria: 1. sex: male/female 2. ethnic origin: Caucasian 3. age: 18 years or older 4. body-mass index2 (BMI): = 18.5 kg/m² and = 30.0 kg/m² 5. good state of health 6. written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial
Safety concerns 1. existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability of the IPs 2. subjects with known diabetes mellitus Typ I and II reported in medical history 3. existing gastrointestinal diseases (e.g. inflammatory bowel disease, coeliac disease, pancreatitis) and/or pre-existing operations of digestive system, which might interfere with the GI-tolerance 4. malabsorption, current or known in history 5. subjects reporting any regular disturbances of the gastrointestinal motility, flatulence, constipation or diarrhoea 6. untreated or non-stabilized thyroid gland disorder 7. untreated or non-stable hypertension 8. known allergic reactions or hypersensitivity to the components of the IP used 9. subjects with known a food allergies unless it is judged as not relevant for the clinical trial by the investigator
Lack of suitability for the clinical trial 10. acute or chronic diseases which may interfere with the aims of the clinical trial 11. history of or current drug or alcohol dependence 12. regular intake of alcoholic food or beverages of = 24 g pure ethanol for male or = 12 g pure ethanol for female per day 13. subjects who are on a diet which could affect the GI-transit 14. regular intake of caffeine containing food or beverages of = 500 mg caffeine per day 15. administration of any investigational medicinal product during the last month prior to individual enrolment of the subject 16. regular treatment with any medication impairing or influencing the gastrointestinal transit time (e.g. laxatives, medication against diarrhoea, antibiotics) or within the last 2 weeks before individual enrolment of the subject 17. subjects, who report a frequent occurrence of migraine attacks
For female subjects with childbearing potential only: 18. positive pregnancy test at screening examination 19. pregnant or lactating women 20. female subjects who do not agree to apply highly effective contraceptive methods
Administrative reasons 21. subjects suspected or known not to follow instructions 22. subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the gastrointestinal tolerability of allulose in 3 different doses (0.6, 0.8 and 1.0 g/kg BW per day) in subjects over 7 days divided into 2 portions per day by mean of total score of Gastrointestinal Symptom Rating Scale (GSRS) compared to Placebo.
- Secondary Outcome Measures
Name Time Method Characterisation of the gastrointestinal tolerability of allulose in 3 different doses (0.6, 0.8 and 1.0 g/kg BW per day) over 7 days divided into 2 portions per day by assessing stool consistency via the Bristol Stool Form Scale (BSFS) compared to Placebo. <br>Characterisation of the gastrointestinal tolerability of allulose in 3 different doses (0.6, 0.8 and 1.0 g/kg BW per day) over 7 days divided into 2 portions per day by mean of dimension score of Gastrointestinal Symptom Rating Scale (GSRS) compared to placebo. <br>Assessment of global tolerability by the subjects and by the investigator compared to placebo. Assessment of frequency and severity of AEs