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Factors That Determine the Responses to Food Ingestion: Protein Load

Factores Que Determinan la Respuesta a la Ingesta: Efecto de la Carga Proteica

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06139237
Enrollment
16
Registered
2023-11-18
Start date
2023-11-30
Completion date
2024-03-31
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

meal ingestion, meal composition, postprandial responses, hedonic sensations, homeostatic sensations

Brief summary

Aim: to determine to what extent meal composition influences postprandial sensations. Experimental design: randomized cross-ower study comparing the responses to a high protein (47.3% protein, 39.4% carbohydrates, 13.3% lipids) versus a balanced (22.2% protein, 67.85% carbohydrates, 9.95% lipids). In each participant the meals (both containing 20.8 g protein and diluted to a volume of 200 mL) will be tested on separate days. Healthy, non-obese participants (8 men and 8 women) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion, at 10 min intervals up to 60 min after the meal and at 30 min up to 120 min after ingestion. Blood samples for biochemical and hormonal determinations will be taken before and after ingestion.

Interventions

OTHERHigh-protein supplement

High protein supplement 200 mL

OTHERBalanced supplement

Balanced supplement 200 mL

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* non-obese

Exclusion criteria

* history of gastrointestinal symptoms * prior obesity * use of medications * history of anosmia and ageusia * current dieting * alcohol abuse * psychological disorders * eating disorders

Design outcomes

Primary

MeasureTime frameDescription
Change in digestive well-being measured after the test meal1 dayChange in average well-being measured by 10 score scales at the end of the test meal.

Secondary

MeasureTime frameDescription
Change in satiety measured after the test meal1 dayChange in average satiety measured by 10 score scales at the end of the test meal
Change in fullness sensation measured after the test meal1 dayChange in average fullness measured by 10 score scales at the end of the test meal
Change in abdominal discomfort/pain sensation measured after the test meal1 dayChange in average abdominal discomfort/pain measured by 10 score scales at the end of the test meal
Change in mood measured after the test meal1 dayChange in average mood measured by 10 score scales at the end of the test meal.

Countries

Spain

Contacts

Primary ContactFernando Azpiroz, MD
azpiroz.fernando@gmail.com+34932746259
Backup ContactGloria Santaliestra
gloria.santaliestra@vhir.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026