NCT07625319

Brief Summary

This study evaluated differences in serum concentrations of selected gut hormones (GLP-1, GIP, cholecystokinin, and omentin) among individuals with varying nutritional status following a standardized meal. A total of 80 adults were enrolled and stratified by BMI. Fasting and postprandial hormone levels were assessed at multiple time points. Additionally, dietary habits, physical activity, body composition, and resting energy expenditure were evaluated to explore their association with hormonal responses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 12, 2026

Last Update Submit

May 28, 2026

Conditions

Obesity

Keywords

Gut hormonesGLP-1GIPCCKOmentinNutritional statusObesityStandardized meal

Outcome Measures

Primary Outcomes (4)

  • Postprandial hormonal response: GLP-1

    Postprandial changes in serum glucagon-like peptide-1 (GLP-1) (pmol/L).

    24 months (analyzes were performed throughout the study period).

  • Postprandial hormonal response: GIP.

    Postprandial changes in serum glucose-dependent insulinotropic polypeptide (GIP) (pg/mL).

    24 months (analyzes were performed throughout the study period).

  • Postprandial hormonal response: cholecystokinin.

    Postprandial changes in serum cholecystokinin (pg/mL).

    24 months (analyzes were performed throughout the study period).

  • Postprandial hormonal response: omentin.

    Postprandial changes in serum omentin (ng/mL).

    24 months (analyzes were performed throughout the study period).

Secondary Outcomes (23)

  • Laboratory parameters: hemoglobin.

    24 months (analyzes were performed throughout the study period).

  • Laboratory parameters: glucose.

    24 months (analyzes were performed throughout the study period).

  • Laboratory parameters: insulin.

    24 months (analyzes were performed throughout the study period).

  • Laboratory parameters: total cholesterol.

    24 months (analyzes were performed throughout the study period).

  • Laboratory parameters: C-reactive protein concentration.

    24 months (analyzes were performed throughout the study period).

  • +18 more secondary outcomes

Study Arms (4)

Normal Body Weight Group

EXPERIMENTAL

Participants with normal body weight (BMI: 19-24.9 kg/m2)

Other: Nutridrink Protein

Overweight Group

EXPERIMENTAL

Participants with overweight (BMI: 25-29.9 kg/m2)

Other: Nutridrink Protein

Obesity I Group

EXPERIMENTAL

Participants with class I obesity (BMI: 30-34.9 kg/m2)

Other: Nutridrink Protein

Obesity II Group

EXPERIMENTAL

Participants with class II and class III obesity (BMI \> 35 kg/m²)

Other: Nutridrink Protein

Interventions

Nutridrink ProteinOTHER

Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).

Normal Body Weight GroupObesity I GroupObesity II GroupOverweight Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women and men aged 40-60

You may not qualify if:

  • disorders of carbohydrate metabolism,
  • endocrine disorders,
  • renal and/or hepatic insufficiency,
  • gastrointestinal diseases,
  • history of gastroenterological or bariatric surgery,
  • pharmacological treatment or use of other agents with known or unknown effects on metabolic and hormonal processes,
  • other diseases potentially affecting the obtained results,
  • pregnancy and lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Bialystok

Bialystok, 15-089, Poland

Location

Related Publications (2)

  • Shah M, Franklin B, Adams-Huet B, Mitchell J, Bouza B, Dart L, Phillips M. Effect of meal composition on postprandial glucagon-like peptide-1, insulin, glucagon, C-peptide, and glucose responses in overweight/obese subjects. Eur J Nutr. 2017 Apr;56(3):1053-1062. doi: 10.1007/s00394-016-1154-8. Epub 2016 Jan 12.

    PMID: 26759261BACKGROUND

  • Dutta B, Tripathy A, Archana PR, Kamath SU. Unraveling the complexities of diet induced obesity and glucolipid dysfunction in metabolic syndrome. Diabetol Metab Syndr. 2025 Jul 22;17(1):292. doi: 10.1186/s13098-025-01837-y.

    PMID: 40696355BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lucyna Ostrowska, Professor

    Department of Dietetics and Clinical Nutrition Medical University of Bialystok

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2026

First Posted

June 4, 2026

Study Start

April 8, 2025

Primary Completion

April 14, 2026

Study Completion

April 14, 2026

Last Updated

June 4, 2026

Record last verified: 2026-05

Locations

PL(1)