GLP-1NCT07240246
Effect of a Dietary Supplement on Hormones Involved in Appetite Regulation in Overweight and Obese Adults
A study testing Intervention: Dietary Supplement with Plant Extracts in people with GLP-1 and Obesity &Amp; Overweight, run by FFoQSI - Austrian Competence Centre for Feed and Food Quality, Safety & Innovation at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- GLP-1, Obesity &Amp; Overweight, Dietary Supplement
- What is being tested?
- Intervention: Dietary Supplement with Plant Extracts
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 24 Oct 2025to 12 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signing the consent form
- BMI 25-40 kg/m²
- Age 18-50 years
Who cannot join
- Known allergy to ingredients in the administered substances
- Type 1 or 2 diabetes
- Pregnancy
- Breastfeeding mothers
- Acute infectious disease
- Renal insufficiency
Trial locations and contacts
1 site in 1 country.
Austria1 site
Salzburger Universitätsklinikum
Salzburg, State of Salzburg, 5020
About this study
Official title: Effect of a Dietary Supplement (FitLine TopShape) on the Incretin Response
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.
Read the detailed description
Obesity is a chronic disease associated with a wide range of adverse health outcomes, including type 2 diabetes mellitus, coronary heart disease, and other metabolic disorders. The global rise in obesity is driven in part by sedentary lifestyles and the widespread availability of calorie-dense foods. According to the World Health Organization, over one billion people worldwide are affected by obesity (BMI ≥ 30 kg/m²), with even more classified as overweight (BMI ≥ 25 kg/m²). This trend poses significant challenges not only to individual health but also to public health systems due to the high costs of treating obesity-related complications.
Lifestyle modification remains the cornerstone of effective weight management. For individuals with overweight but without comorbidities, the primary goal is to prevent further weight gain through increased physical activity and dietary adjustments. Evidence suggests that even modest weight loss of 5-10% can lead to clinically meaningful improvements in cardiovascular risk factors.
In this context, dietary supplements that support appetite regulation and satiety enhancement are of growing interest. Several plant extracts-including bitter melon, yerba mate, green tea, turmeric, and others-have shown potential to stimulate the secretion of glucagon-like peptide-1 (GLP-1), a gut hormone involved in satiety signaling, appetite suppression, and insulin secretion.
GLP-1 is secreted by intestinal L-cells in response to food intake and acts via GLP-1 receptors. However, native GLP-1 has a short half-life of approximately two minutes due to rapid degradation by the enzyme dipeptidyl peptidase-4 (DPP-4). Therefore, strategies that stimulate GLP-1 secretion or inhibit DPP-4 activity may enhance satiety and support weight control. While promising, current evidence is largely limited to in vitro and animal studies, and human data are lacking.
This randomized, double-blind, placebo-controlled clinical trial aims to investigate the effects of a commercially available dietary supplement (FitLine TopShape) on GLP-1 secretion and related metabolic parameters. The supplement contains extracts from purslane, bitter melon, dandelion, mulberry, yerba mate, and green coffee beans. Preliminary user data from an observational study (n=40) suggest that daily intake of the supplement may increase satiety and promote weight loss (mean reduction: -1.32 kg over four weeks; unpublished). In vitro assays indicate that the bioactive compounds may reduce DPP-4 activity and increase GLP-1 secretion (unpublished).
The primary objective of this study is to assess the effect of the supplement on GLP-1 secretion. Secondary outcomes include changes in DPP-4 activity, gastric inhibitory peptide (GIP), insulin, and C-peptide levels. Subjective measures of satiety, appetite, and food intake will be collected via validated questionnaires. Anthropometric data (weight, height, waist and hip circumference) will be recorded at baseline and after 12 weeks of intervention.
Participants (BMI 25-40 kg/m², age 18-50 years) will be randomized 1:1 to receive either the dietary supplement or placebo for 12 weeks. Blood samples will be collected in fasting state and at multiple time points post-ingestion of the capsule and a standardized liquid meal. The study will evaluate both acute hormonal responses and long-term effects on weight control.
- Conditions
- GLP-1, Obesity &Amp; Overweight, Dietary Supplement
- Being tested
- Intervention: Dietary Supplement with Plant Extracts, Placebo
- Keywords
- Obesity, Overweight, Incretins, Dietary Supplement, Plant Extract, Appetite Regulation, Dipeptidyl-Peptidase IV, Glucagon-Like Peptide 1, Gastric Inhibitory Polypeptide
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: Dietary Supplement with Plant ExtractsDietary supplement
Capsule containing a blend of plant extracts, administered twice daily three capsules (total six capsules), 30-60 minutes before main meals, for 12 weeks.
PlaceboOther
Matching capsule without active plant extracts, administered twice daily three capsules (in total six), 30-60 minutes before main meals, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement | Active comparator | 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) Receives: Dietary Supplement: Intervention: Dietary Supplement with Plant Extracts |
| Placebo | Placebo comparator | Participants receive a capsule preparation containing hypromellose, calcium phosphate, inulin and yellow iron oxide (E172 - capsule colouring agent) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1 secretion
Taking the dietary supplement over a period of 12 weeks changes GLP-1 secretion (area under the curve (AUC) over 60 minutes) in overweight or obese subjects* compared to the start of the study (AUC over 60 minutes).
Measured: 12 weeks
Secondary outcomes (13)
Intervention vs. Placebo
Taking the dietary supplement over a period of 12 weeks changes GLP-1, DPP-4, GIP, and insulin secretion (AUC over 60 min) in overweight or obese subjects* compared to taking a placebo (AUC over 60 min).
Measured: 12 weeks
Liquid Meal
Taking the dietary supplement over a period of 12 weeks changes GLP-1, DPP-4, GIP, and insulin secretion (AUC over 60 min) in overweight or obese subjects* after consuming a standardised liquid meal compared to intake at the start of the study (AUC over 60 min).
Measured: 12 weeks
Liquid Meal: Intervention vs. Placebo
Taking the dietary supplement over a period of 12 weeks changes GLP-1, DPP-4, GIP, and insulin secretion (AUC over 60 min) in overweight or obese subjects* after consuming a standardised liquid meal compared to taking a placebo (AUC over 60 min).
Measured: 12 weeks
Body weight
Taking the dietary supplement over a period of 12 weeks leads to changes in body weight (kg).
Measured: 12 weeks
Body mass index (BMI) in kg/m²
BMI in kg/m² will be determined using weight (kg) and height (m). Taking the dietary supplement over a period of 12 weeks leads to changes in BMI.
Measured: 12 weeks
Abdominal Circumference
Taking the dietary supplement over a period of 12 weeks leads to changes in the abdominal circumference (cm).
Measured: 12 weeks
Waist to Hip Ratio
Taking the dietary supplement leads to changes in the waist-hip ratio (cm waist/cm hip = WHR).
Measured: 12 weeks
Changes in Control of Eating Questionnaire (CoEQ)
Participants report on their control of eating by answering the Control of Eating Questionnaire (CoEQ) with 19 questions. Rating on a horizontal, non-calibrated line of 10 cm, ranging from very low (0) to very high (10).
Measured: 12 weeks
Visual analog scale (VAS) to assess hunger
Visual analog scale (VAS) to assess hunger on a horizontal, non-calibrated line of 10 cm, ranging from not hungry at all (0) to very hungry (10)
Measured: 12 weeks
Visual analog scale (VAS) to assess satiation
Visual analog scale (VAS) to assess satiation (process that leads to the termination of eating) on a horizontal, non-calibrated line of 10 cm, ranging from completely empty (0) to cannot eat another bite (10)
Measured: 12 weeks
Visual analog scale (VAS) to assess desire to eat
Visual analog scale to assess desire to eat on a horizontal, non-calibrated line of 10 cm, ranging from very low (0) to very strong (10)
Measured: 12 weeks
Visual analog scale (VAS) to assess the amount that can be eaten right now
Visual analog scale to assess the amount that can be eaten right now on a horizontal, non-calibrated line of 10 cm, ranging from not at all (0) to a large amount (10)
Measured: 12 weeks
Visual analog scale (VAS) to assess satiety
Visual analog scale to assess satiety (feeling of fullness that persists after eating suppressing further energy intake) on a horizontal, non-calibrated line of 10 cm, ranging from not full at all (0) to totally full (10)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start24 Oct 2025
- Primary completion11 Mar 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for GLP-1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as a 3-month parallel, double-blind, randomised, placebo-controlled trial involving adults who are overweight or obese (BMI 25-40; age 18-50 years). Participants will be randomised in a 1:1 ratio to two arms: (1) placebo and (2) intervention group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- FFoQSI - Austrian Competence Centre for Feed and Food Quality, Safety & Innovation
- Sponsor type
- University, hospital or other
- Collaborators
- Salzburger Universitätsklinkum, University of Applied Sciences Upper Austria
- Responsible party
- Sponsor
- Investigators
- Daniel Weghuber, Prim. Univ. Prof. Dr., Study director, Salzburger Universitätsklinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240246
- Sponsor's protocol ID
- 1098/2025
- Status last verified
- Jun 2026
- First submitted
- 24 Sep 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu CY, Huang CJ, Huang LH, Chen IJ, Chiu JP, Hsu CH. Effects of green tea extract on insulin resistance and glucagon-like peptide 1 in patients with type 2 diabetes and lipid abnormalities: a randomized, double-blinded, and placebo-controlled trial. PLoS One. 2014 Mar 10;9(3):e91163. doi: 10.1371/journal.pone.0091163. eCollection 2014.
PubMed 24614112Stenlid R, Manell H, Halldin M, Kullberg J, Ahlstrom H, Manukyan L, Weghuber D, Paulmichl K, Zsoldos F, Bergsten P, Forslund A. High DPP-4 Concentrations in Adolescents Are Associated With Low Intact GLP-1. J Clin Endocrinol Metab. 2018 Aug 1;103(8):2958-2966. doi: 10.1210/jc.2018-00194.
PubMed 29850829Stenlid R, Cerenius SY, Wen Q, Aydin BK, Manell H, Chowdhury A, Kristinsson H, Ciba I, Gjessing ES, Morwald K, Gomahr J, Heu V, Weghuber D, Forslund A, Bergsten P. Adolescents with obesity treated with exenatide maintain endogenous GLP-1, reduce DPP-4, and improve glycemic control. Front Endocrinol (Lausanne). 2023 Nov 1;14:1293093. doi: 10.3389/fendo.2023.1293093. eCollection 2023.
PubMed 38027106Dalton M, Finlayson G, Hill A, Blundell J. Preliminary validation and principal components analysis of the Control of Eating Questionnaire (CoEQ) for the experience of food craving. Eur J Clin Nutr. 2015 Dec;69(12):1313-7. doi: 10.1038/ejcn.2015.57. Epub 2015 Apr 8.
PubMed 25852028Gabe MBN, Breitschaft A, Knop FK, Hansen MR, Kirkeby K, Rathor N, Adrian CL. Effect of oral semaglutide on energy intake, appetite, control of eating and gastric emptying in adults living with obesity: A randomized controlled trial. Diabetes Obes Metab. 2024 Oct;26(10):4480-4489. doi: 10.1111/dom.15802. Epub 2024 Jul 31.
PubMed 39082206Muller TD, Finan B, Bloom SR, D'Alessio D, Drucker DJ, Flatt PR, Fritsche A, Gribble F, Grill HJ, Habener JF, Holst JJ, Langhans W, Meier JJ, Nauck MA, Perez-Tilve D, Pocai A, Reimann F, Sandoval DA, Schwartz TW, Seeley RJ, Stemmer K, Tang-Christensen M, Woods SC, DiMarchi RD, Tschop MH. Glucagon-like peptide 1 (GLP-1). Mol Metab. 2019 Dec;30:72-130. doi: 10.1016/j.molmet.2019.09.010. Epub 2019 Sep 30.
PubMed 31767182Smith NK, Hackett TA, Galli A, Flynn CR. GLP-1: Molecular mechanisms and outcomes of a complex signaling system. Neurochem Int. 2019 Sep;128:94-105. doi: 10.1016/j.neuint.2019.04.010. Epub 2019 Apr 17.
PubMed 31002893Adam TC, Westerterp-Plantenga MS. Glucagon-like peptide-1 release and satiety after a nutrient challenge in normal-weight and obese subjects. Br J Nutr. 2005 Jun;93(6):845-51. doi: 10.1079/bjn20041335.
PubMed 16022753Yumuk V, Tsigos C, Fried M, Schindler K, Busetto L, Micic D, Toplak H; Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015;8(6):402-24. doi: 10.1159/000442721. Epub 2015 Dec 5.
PubMed 26641646Aaseth J, Ellefsen S, Alehagen U, Sundfor TM, Alexander J. Diets and drugs for weight loss and health in obesity - An update. Biomed Pharmacother. 2021 Aug;140:111789. doi: 10.1016/j.biopha.2021.111789. Epub 2021 May 31.
PubMed 34082399Ackermann RT, Edelstein SL, Narayan KM, Zhang P, Engelgau MM, Herman WH, Marrero DG; Diabetes Prevention Program Research Group. Changes in health state utilities with changes in body mass in the Diabetes Prevention Program. Obesity (Silver Spring). 2009 Dec;17(12):2176-81. doi: 10.1038/oby.2009.114. Epub 2009 Apr 23.
PubMed 19390518Planes-Munoz D , Lopez-Nicolas R , Gonzalez-Bermudez CA , Ros-Berruezo G , Frontela-Saseta C . In vitro effect of green tea and turmeric extracts on GLP-1 and CCK secretion: the effect of gastrointestinal digestion. Food Funct. 2018 Oct 17;9(10):5245-5250. doi: 10.1039/c8fo01334a.
PubMed 30226521Cooper-Leavitt ET, Shin MJ, Beus CG, Chiu AT, Parker G, Radford JH, Evans EP, Edwards IT, Arroyo JA, Reynolds PR, Bikman BT. The Incretin Effect of Yerba Mate (Ilex paraguariensis) Is Partially Dependent on Gut-Mediated Metabolism of Ferulic Acid. Nutrients. 2025 Feb 9;17(4):625. doi: 10.3390/nu17040625.
PubMed 40004954Romdhoni MF, Doewes M, Soetrisno S, Febrinasari RP. Antidiabetic Activity of Momordica charantia Extracts Through Incretin Pathway in Streptozotocin-Nicotinamide Induced Diabetic Rat Depends on Dose Differences. Avicenna J Med Biotechnol. 2025 Jan-Mar;17(1):47-55. doi: 10.18502/ajmb.v17i1.17677.
PubMed 40094091Bhat GA, Khan HA, Alhomida AS, Sharma P, Singh R, Paray BA. GLP-I secretion in healthy and diabetic Wistar rats in response to aqueous extract of Momordica charantia. BMC Complement Altern Med. 2018 May 18;18(1):162. doi: 10.1186/s12906-018-2227-4.
PubMed 29776414
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Dietary Supplement (FitLine TopShape) on the Incretin Response
- ClinicalTrials.gov ID
- NCT07240246
- Acronym / sponsor ID
- 1098/2025
- Conditions
- GLP-1, Obesity &Amp; Overweight, Dietary Supplement
- Keywords
- Obesity, Overweight, Incretins, Dietary Supplement, Plant Extract, Appetite Regulation, Dipeptidyl-Peptidase IV, Glucagon-Like Peptide 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- FFoQSI - Austrian Competence Centre for Feed and Food Quality, Safety & InnovationUniversity, hospital or other
- Collaborators
- Salzburger Universitätsklinkum, University of Applied Sciences Upper Austria
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity is a chronic disease associated with a wide range of adverse health outcomes, including type 2 diabetes mellitus, coronary heart disease, and other metabolic disorders. The global rise in obesity is driven in part by sedentary lifestyles and the widespread availability of calorie-dense foods. According to the World Health Organization, over one billion people worldwide are affected by obesity (BMI ≥ 30 kg/m²), with even more classified as overweight (BMI ≥ 25 kg/m²). This trend poses significant challenges not only to individual health but also to public health systems due to the high costs of treating obesity-related complications.
Lifestyle modification remains the cornerstone of effective weight management. For individuals with overweight but without comorbidities, the primary goal is to prevent further weight gain through increased physical activity and dietary adjustments. Evidence suggests that even modest weight loss of 5-10% can lead to clinically meaningful improvements in cardiovascular risk factors.
In this context, dietary supplements that support appetite regulation and satiety enhancement are of growing interest. Several plant extracts-including bitter melon, yerba mate, green tea, turmeric, and others-have shown potential to stimulate the secretion of glucagon-like peptide-1 (GLP-1), a gut hormone involved in satiety signaling, appetite suppression, and insulin secretion.
GLP-1 is secreted by intestinal L-cells in response to food intake and acts via GLP-1 receptors. However, native GLP-1 has a short half-life of approximately two minutes due to rapid degradation by the enzyme dipeptidyl peptidase-4 (DPP-4). Therefore, strategies that stimulate GLP-1 secretion or inhibit DPP-4 activity may enhance satiety and support weight control. While promising, current evidence is largely limited to in vitro and animal studies, and human data are lacking.
This randomized, double-blind, placebo-controlled clinical trial aims to investigate the effects of a commercially available dietary supplement (FitLine TopShape) on GLP-1 secretion and related metabolic parameters. The supplement contains extracts from purslane, bitter melon, dandelion, mulberry, yerba mate, and green coffee beans. Preliminary user data from an observational study (n=40) suggest that daily intake of the supplement may increase satiety and promote weight loss (mean reduction: -1.32 kg over four weeks; unpublished). In vitro assays indicate that the bioactive compounds may reduce DPP-4 activity and increase GLP-1 secretion (unpublished).
The primary objective of this study is to assess the effect of the supplement on GLP-1 secretion. Secondary outcomes include changes in DPP-4 activity, gastric inhibitory peptide (GIP), insulin, and C-peptide levels. Subjective measures of satiety, appetite, and food intake will be collected via validated questionnaires. Anthropometric data (weight, height, waist and hip circumference) will be recorded at baseline and after 12 weeks of intervention.
Participants (BMI 25-40 kg/m², age 18-50 years) will be randomized 1:1 to receive either the dietary supplement or placebo for 12 weeks. Blood samples will be collected in fasting state and at multiple time points post-ingestion of the capsule and a standardized liquid meal. The study will evaluate both acute hormonal responses and long-term effects on weight control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is designed as a 3-month parallel, double-blind, randomised, placebo-controlled trial involving adults who are overweight or obese (BMI 25-40; age 18-50 years). Participants will be randomised in a 1:1 ratio to two arms: (1) placebo and (2) intervention group.
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement | Active comparator | Dietary Supplement: Intervention: Dietary Supplement with Plant ExtractsParticipants 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 | Placebo comparator | Other: PlaceboParticipants receive a capsule preparation containing hypromellose, calcium phosphate, inulin and yellow iron oxide (E172 - capsule colouring agent) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Signing the consent form
- BMI 25-40 kg/m²
- Age 18-50 years
Key exclusion criteria (6 listed)
- Known allergy to ingredients in the administered substances
- Type 1 or 2 diabetes
- Pregnancy
- Breastfeeding mothers
- Acute infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention: Dietary Supplement with Plant ExtractsCapsule containing a blend of plant extracts, administered twice daily three capsules (total six capsules), 30-60 minutes before main meals, for 12 weeks. | Dietary supplement | Dietary Supplement |
| PlaceboMatching capsule without active plant extracts, administered twice daily three capsules (in total six), 30-60 minutes before main meals, for 12 weeks. | Other | Placebo |
Primary outcome
GLP-1 secretion
Time frame: 12 weeks
Taking the dietary supplement over a period of 12 weeks changes GLP-1 secretion (area under the curve (AUC) over 60 minutes) in overweight or obese subjects* compared to the start of the study (AUC over 60 minutes).
13 secondary outcomes
Intervention vs. Placebo
Time frame: 12 weeks
Liquid Meal
Time frame: 12 weeks
Liquid Meal: Intervention vs. Placebo
Time frame: 12 weeks
Body weight
Time frame: 12 weeks
Body mass index (BMI) in kg/m²
Time frame: 12 weeks
Abdominal Circumference
Time frame: 12 weeks
Waist to Hip Ratio
Time frame: 12 weeks
Changes in Control of Eating Questionnaire (CoEQ)
Time frame: 12 weeks
Visual analog scale (VAS) to assess hunger
Time frame: 12 weeks
Visual analog scale (VAS) to assess satiation
Time frame: 12 weeks
Visual analog scale (VAS) to assess desire to eat
Time frame: 12 weeks
Visual analog scale (VAS) to assess the amount that can be eaten right now
Time frame: 12 weeks
Visual analog scale (VAS) to assess satiety
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 24614112Liu CY, Huang CJ, Huang LH, Chen IJ, Chiu JP, Hsu CH. Effects of green tea extract on insulin resistance and glucagon-like peptide 1 in patients with type 2 diabetes and lipid abnormalities: a randomized, double-blinded, and placebo-controlled trial. PLoS One. 2014 Mar 10;9(3):e91163. doi: 10.1371/journal.pone.0091163. eCollection 2014.
- Background: PubMed 29850829Stenlid R, Manell H, Halldin M, Kullberg J, Ahlstrom H, Manukyan L, Weghuber D, Paulmichl K, Zsoldos F, Bergsten P, Forslund A. High DPP-4 Concentrations in Adolescents Are Associated With Low Intact GLP-1. J Clin Endocrinol Metab. 2018 Aug 1;103(8):2958-2966. doi: 10.1210/jc.2018-00194.
- Background: PubMed 38027106Stenlid R, Cerenius SY, Wen Q, Aydin BK, Manell H, Chowdhury A, Kristinsson H, Ciba I, Gjessing ES, Morwald K, Gomahr J, Heu V, Weghuber D, Forslund A, Bergsten P. Adolescents with obesity treated with exenatide maintain endogenous GLP-1, reduce DPP-4, and improve glycemic control. Front Endocrinol (Lausanne). 2023 Nov 1;14:1293093. doi: 10.3389/fendo.2023.1293093. eCollection 2023.
- Background: PubMed 25852028Dalton M, Finlayson G, Hill A, Blundell J. Preliminary validation and principal components analysis of the Control of Eating Questionnaire (CoEQ) for the experience of food craving. Eur J Clin Nutr. 2015 Dec;69(12):1313-7. doi: 10.1038/ejcn.2015.57. Epub 2015 Apr 8.
- Background: PubMed 39082206Gabe MBN, Breitschaft A, Knop FK, Hansen MR, Kirkeby K, Rathor N, Adrian CL. Effect of oral semaglutide on energy intake, appetite, control of eating and gastric emptying in adults living with obesity: A randomized controlled trial. Diabetes Obes Metab. 2024 Oct;26(10):4480-4489. doi: 10.1111/dom.15802. Epub 2024 Jul 31.
- Background: PubMed 31767182Muller TD, Finan B, Bloom SR, D'Alessio D, Drucker DJ, Flatt PR, Fritsche A, Gribble F, Grill HJ, Habener JF, Holst JJ, Langhans W, Meier JJ, Nauck MA, Perez-Tilve D, Pocai A, Reimann F, Sandoval DA, Schwartz TW, Seeley RJ, Stemmer K, Tang-Christensen M, Woods SC, DiMarchi RD, Tschop MH. Glucagon-like peptide 1 (GLP-1). Mol Metab. 2019 Dec;30:72-130. doi: 10.1016/j.molmet.2019.09.010. Epub 2019 Sep 30.
- Background: PubMed 31002893Smith NK, Hackett TA, Galli A, Flynn CR. GLP-1: Molecular mechanisms and outcomes of a complex signaling system. Neurochem Int. 2019 Sep;128:94-105. doi: 10.1016/j.neuint.2019.04.010. Epub 2019 Apr 17.
- Background: PubMed 16022753Adam TC, Westerterp-Plantenga MS. Glucagon-like peptide-1 release and satiety after a nutrient challenge in normal-weight and obese subjects. Br J Nutr. 2005 Jun;93(6):845-51. doi: 10.1079/bjn20041335.
- Background: PubMed 26641646Yumuk V, Tsigos C, Fried M, Schindler K, Busetto L, Micic D, Toplak H; Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015;8(6):402-24. doi: 10.1159/000442721. Epub 2015 Dec 5.
- Background: PubMed 34082399Aaseth J, Ellefsen S, Alehagen U, Sundfor TM, Alexander J. Diets and drugs for weight loss and health in obesity - An update. Biomed Pharmacother. 2021 Aug;140:111789. doi: 10.1016/j.biopha.2021.111789. Epub 2021 May 31.
- Background: PubMed 19390518Ackermann RT, Edelstein SL, Narayan KM, Zhang P, Engelgau MM, Herman WH, Marrero DG; Diabetes Prevention Program Research Group. Changes in health state utilities with changes in body mass in the Diabetes Prevention Program. Obesity (Silver Spring). 2009 Dec;17(12):2176-81. doi: 10.1038/oby.2009.114. Epub 2009 Apr 23.
- Background: PubMed 30226521Planes-Munoz D , Lopez-Nicolas R , Gonzalez-Bermudez CA , Ros-Berruezo G , Frontela-Saseta C . In vitro effect of green tea and turmeric extracts on GLP-1 and CCK secretion: the effect of gastrointestinal digestion. Food Funct. 2018 Oct 17;9(10):5245-5250. doi: 10.1039/c8fo01334a.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Weghuber, Prim. Univ. Prof. Dr. study director
Salzburger Universitätsklinikum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: Dietary Supplement with Plant Extracts in people with GLP-1 and Obesity &Amp; Overweight, run by FFoQSI - Austrian Competence Centre for Feed and Food Quality, Safety & Innovation at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GLP-1 secretion (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07240246, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.