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Effect of a Dietary Supplement (FitLine TopShape) on the Incretin Response

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Obesity is a chronic condition linked to numerous health risks and affects more than one billion people worldwide. While pharmacological treatments such as incretin-based therapies are available, they may have side effects, are not suitable for all patients, and adherence can be limited. Dietary supplements that influence appetite and satiety may represent an alternative or complementary approach. This study will evaluate whether a dietary supplement containing plant extracts stimulates the intestinal incretin response. The primary focus is the effect on glucagon-like peptide-1 (GLP-1) secretion. Secondary outcomes include dipeptidyl peptidase-4 (DPP-4), gastric inhibitory peptide (GIP), and insulin, as well as measures of appetite, satiety, food intake, and anthropometrics. The trial is designed as a 12-week, double-blind, randomized, placebo-controlled parallel-group study in adults with overweight or obesity (BMI 25-40, age 18-50). Participants will receive either the dietary supplement or placebo. Blood samples will be collected at baseline and after 12 weeks, both fasting and following capsule intake and a standardized liquid meal. Anthropometric measurements and visual analog scales (VAS) for hunger and satiety will also be assessed.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• Signing the consent form

• BMI 25-40 kg/m²

• Age 18-50 years

Locations
Other Locations
Austria
Salzburger Universitätsklinikum
RECRUITING
Salzburg
Contact Information
Primary
Verena Preinfalk, Dr.
verena.preinfalk@ffoqsi.at
+435080444475
Backup
Alice König, Dr.
alice.koenig@fh-wels.at
+435080448852
Time Frame
Start Date: 2025-10-24
Estimated Completion Date: 2026-03-11
Participants
Target number of participants: 40
Treatments
Active_comparator: Dietary Supplement
Participants receive a dietary supplement: Capsule preparation containing hypromellose, calcium phosphate, inulin, yeast extract (Saccharomyces cerevisiae), bitter melon extract, green coffee bean extract, white mulberry extract, purslane extract, peppermint leaf extract, dandelion extract, green mate extract, zinc gluconate, ginger extract, biotin and yellow iron oxide (E172 - capsule colouring)
Placebo_comparator: Placebo
Participants receive a capsule preparation containing hypromellose, calcium phosphate, inulin and yellow iron oxide (E172 - capsule colouring agent)
Related Therapeutic Areas
Sponsors
Collaborators: Salzburger Universitätsklinkum, University of Applied Sciences Upper Austria
Leads: FFoQSI - Austrian Competence Centre for Feed and Food Quality, Safety & Innovation

This content was sourced from clinicaltrials.gov