Factors That Determine the Responses to Food Ingestion: Protein Load

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Other: High-protein supplement; Other: Balanced supplement

• Registration Number: NCT06139237
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-14
• Last Update Submitted: 2023-11-14
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-01
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High-protein supplement	High-protein supplement	The high-protein supplements contains 47.3% protein, 39.4% carbohydrates, 13.3% lipids. A dose containing 20.8 g protein and diluted to a volume of 200 mL will be administered (187 Kcal).
Balanced supplement	Balanced supplement	The high-protein supplements 22.2% protein, 67.85% carbohydrates, 9.95% lipids. A dose containing 20.8 g protein and diluted to a volume of 200 mL will be administered (399.3 Kcal)

Primary Outcome Measures

Name	Time	Method
Change in digestive well-being measured after the test meal	1 day	Change in average well-being measured by 10 score scales at the end of the test meal.

Secondary Outcome Measures

Name	Time	Method
Change in satiety measured after the test meal	1 day	Change in average satiety measured by 10 score scales at the end of the test meal
Change in fullness sensation measured after the test meal	1 day	Change 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 meal	1 day	Change in average abdominal discomfort/pain measured by 10 score scales at the end of the test meal
Change in mood measured after the test meal	1 day	Change in average mood measured by 10 score scales at the end of the test meal.

Trial Locations

Locations (1)

University Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain