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Clinical Trials/NCT06139237
NCT06139237
Not yet recruiting
Not Applicable

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

Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country16 target enrollmentNovember 2023
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
16
Locations
1
Primary Endpoint
Change in digestive well-being measured after the test meal
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2023
End Date
March 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in digestive well-being measured after the test meal

Time Frame: 1 day

Change in average well-being measured by 10 score scales at the end of the test meal.

Secondary Outcomes

  • Change in satiety measured after the test meal(1 day)
  • Change in fullness sensation measured after the test meal(1 day)
  • Change in abdominal discomfort/pain sensation measured after the test meal(1 day)
  • Change in mood measured after the test meal(1 day)

Study Sites (1)

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