Effect of a Dietary Supplement on Hormones Involved in Appetite Regulation in Overweight and Obese Adults

NCT07240246 | Active Not Recruiting

• 1 other identifier: 1098/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

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; Gastric Inhibitory Polypeptide

Outcome Measures

Primary Outcomes (1)

• 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).

  12 weeks

Secondary Outcomes (13)

• Intervention vs. Placebo

  12 weeks

• Liquid Meal

  12 weeks

• Liquid Meal: Intervention vs. Placebo

  12 weeks

• Body weight

  12 weeks

• Body mass index (BMI) in kg/m²

  12 weeks

Study Arms (2)

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)

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)

Other: Placebo

Interventions

Intervention: Dietary Supplement with Plant Extracts DIETARY_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.

Dietary Supplement

Placebo OTHER

Matching capsule without active plant extracts, administered twice daily three capsules (in total six), 30-60 minutes before main meals, for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signing the consent form
• BMI 25-40 kg/m²
• Age 18-50 years

You may not qualify if:

• Known allergy to ingredients in the administered substances
• Type 1 or 2 diabetes
• Pregnancy
• Breastfeeding mothers
• Acute infectious disease
• Renal insufficiency

Sponsors & Collaborators

• FFoQSI - Austrian Competence Centre for Feed and Food Quality, Safety & Innovation: lead
• Salzburger Universitätsklinkum: collaborator
• University of Applied Sciences Upper Austria: collaborator

Study Sites (1)

Salzburger Universitätsklinikum

Salzburg, Salzburg, 5020, Austria

Location

Related Publications (18)

• 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.

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  PMID: 26641646 BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Plant Extracts

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Officials

• Daniel Weghuber, Prim. Univ. Prof. Dr.

  Salzburger Universitätsklinikum

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: November 20, 2025
• Study Start: October 24, 2025
• Primary Completion: March 11, 2026
• Study Completion (Estimated): May 11, 2026
• Last Updated: March 30, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)