Multicentre, prospective, randomised, double-blind, placebo-controlled study to evaluate the mechanism of a novel medical device for long-lasting weight loss in overweight and obesity.
- Conditions
- E66.9Obesity, unspecified
- Registration Number
- DRKS00008922
- Lead Sponsor
- Praxis Dr. med. von Seck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting withdrawn before recruiting started
- Sex
- All
- Target Recruitment
- 15
1. Age: 18 to 95 years
2. Gender: Männer und Frauen
3. BMI between 25 and 29.9 with concomitant obesity-related health disorders, an abdominal
fat distribution pattern, diseases which are aggravated by obesity or a high degree of psychosocial pressure.
4. BMI = 30 kg / m2
5. Capacity to consent
6. Signed consent form
7. Desire to reduce weight
8. Failure of a basic program (nutritional, exercise and behavioural therapy), i. e. less than 5% weight reductiom / 3 to 6 months or weight regain
1. Weight reduction > 5% over the last months before inclusion into the study
2. Individuals with denture, esp. worn with implants or pivot teeth
3. Less than 10 teeth / joint, teeth with maximally mild to moderate paradontal Zähne pro Kiefer mit maximal leichter bis mittelschwerer paradontal defects
4. Craniomandibular problems
5. Wasting diseases
6. Clinical diagnosis of an eating disorder
7. Medication with substances influencing weight or appetite (i. e. steroids, psyotropic drugs, diuretics)
8. Major surgical interventions durign the last 3 months
9. Pregnancy or breastfeeding women
10. Mental disorders or non-compliance
11. Inability to take in meals on a regularly
12. Incapacity to give informed consent
13. Secondary causes of obesity, i.e. der Adipositas, wie hypothyrodism, cushings syndrome, hypogonadism, hypothalimic tumors, or metabolic decompensation in diabetes mellitus
14. Newly diagnosed diabetes mellitus during the last 6 months before inclusion
15. HbA1C > 9% in diabetics
16. Uncontrolled arterial hypertension
17. Initiation / change of medication for a chronic disease during the last 3 months before inclusion
18. Participation in another clinical trial
19. Participation in another weight reduction program in the last 3 months
20. Unintended weight loss in the last 3 months
21. Participation in another therapy program during the course of the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proof of mechanism (duration and frequency of chewing, amount of saliva, size of ingested standardised meal, sensation of hunger (questionnaire + biochemical), at 3 time points at the beginning and after 3 months; control / placebo / verum)
- Secondary Outcome Measures
Name Time Method 1. Evidence for changes in behaviour (intra-individual comparison of parameters at the beginning and after 3 months of the observation period)<br>2. Effect of the medical device on the feeling of hunger (questionnaire + biochemical), at 3 time points at the beginning and after 3 months; control / placebo / verum)<br>