NCT07627802

Brief Summary

This study evaluated differences in serum concentrations of ghrelin among individuals with varying nutritional status following a standardized meal. A total of 80 adults were enrolled and stratified by BMI. Fasting and postprandial ghrelin 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
29 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
22 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 13, 2026

Last Update Submit

June 2, 2026

Conditions

Obesity

Keywords

ghrelinNutritional statusObesityPostpriandal response

Outcome Measures

Primary Outcomes (1)

  • Postprandial serum ghrelin concentration

    Change in serum ghrelin concentration (pg/mL) over 4 hours following standardized meal intake in participants with different nutritional status. Measurements will be assessed at predefined time points postprandially.

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

Secondary Outcomes (24)

  • Hemoglobin concentration

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

  • White blood cell count

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

  • Platelet count

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

  • Fasting glucose concentration

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

  • Fasting insulin concentration

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

  • +19 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 consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.

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:

  • type I and II diabetes,
  • exacerbated coronary artery disease,
  • endocrine disorders,
  • pregnancy and lactation period,
  • use of hormonal contraception or hormone replacement therapy, steroid therapy, antiretroviral therapy,
  • surgical or pharmacological history obesity treatment,
  • pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Bialystok

Bialystok, Poland, 15-089, Poland

Location

Related Publications (2)

  • Dani C, Giachetti S, Mura M, Tedesco S, Rossi E, Cassioli E, Tarchi L, Micali N, Ricca V, Castellini G. Investigating ghrelin and its isoforms in eating disorders: a network meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2025 Oct 2;142:111489. doi: 10.1016/j.pnpbp.2025.111489. Epub 2025 Sep 10.

    PMID: 40939947BACKGROUND

  • Clarke GS, Page AJ, Eldeghaidy S. The gut-brain axis in appetite, satiety, food intake, and eating behavior: Insights from animal models and human studies. Pharmacol Res Perspect. 2024 Oct;12(5):e70027. doi: 10.1002/prp2.70027.

    PMID: 39417406BACKGROUND

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
Model Details: Crossover Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 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)