Healthy Subjects
Conditions
Keywords
Fat excretion
Brief summary
The study aims to evaluate the effect of Litramine on fecal fat excretion in healthy subjects, to provide more comprehensive and robust clinical evidence in its mode of action for the treatment of obesity and weight management through dietary fat binding.
Interventions
DEVICELitramine
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
DEVICEPlacebo
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Sponsors
InQpharm Group
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 20-30 kg/m2 * Accustomed to 3 main meals/day * Commitment to avoid the use of other weight management products during study * Females' agreement to use appropriate birth control methods during the active study period * Self-reported regular bowel movement (1-2 times per day) * Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
Exclusion criteria
* Known sensitivity to the ingredients of the device * Diabetes mellitus (type 1 or 2) * History or clinical signs of endocrine disorders * Clinically relevant excursions of safety parameter * Current use of anti-depressants * Presence of acute or chronic gastrointestinal disease * Uncontrolled hypertension (more than 160/110 mm Hg) * Stenosis in the gastrointestinal tract * Bariatric surgery * Abdominal surgery within the last 6 months prior to enrollment * History of eating disorders such as bulimia, anorexia nervosa within the past 12 months * Other serious organ or systemic diseases such as cancer * Any medication that could influence gastrointestinal functions * Pregnancy or nursing * Any medication or use of products for the treatment of obesity within 6 weeks prior to enrolment * History of abuse of drugs, alcohol or medication * Presence of other factor(s) that, in the investigator's judgment, should preclude subject participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between Litramine and placebo in changes of percentage fecal fat excretion after intervention | 7 days per intervention | The amount of fat excreted in the feces will be quantified by the near-infrared reflectance analysis (NIRA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Full blood count | Approximately 45 days | Analysis of hemoglobin, hematocrit, erythrocytes, thrombocytes, and leucocytes |
| Clinical chemistry | Approximately 45 days | Liver function, renal function, protein metabolism, lipid metabolism |
| Blood pressure | Approximately 45 days | Sitting blood pressure and heart rate will be measured using standard devices |
Countries
Germany
Outcome results
None listed