Factors That Determine the Responses to Food Ingestion: Protein Load

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06139237
• Other study ID #: PR(AG)338/2016P
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: March 2024

Study information

• Verified date: November 2023
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Fernando Azpiroz, MD
• Phone: +34932746259
• Email: azpiroz.fernando[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• High-protein supplement
High protein supplement 200 mL
• Balanced supplement
Balanced supplement 200 mL

Locations

Country	Name	City	State
Spain	University Hospital Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in digestive well-being measured after the test meal	Change in average well-being measured by 10 score scales at the end of the test meal.	1 day
Secondary	Change in satiety measured after the test meal	Change in average satiety measured by 10 score scales at the end of the test meal	1 day
Secondary	Change in fullness sensation measured after the test meal	Change in average fullness measured by 10 score scales at the end of the test meal	1 day
Secondary	Change in abdominal discomfort/pain sensation measured after the test meal	Change in average abdominal discomfort/pain measured by 10 score scales at the end of the test meal	1 day
Secondary	Change in mood measured after the test meal	Change in average mood measured by 10 score scales at the end of the test meal.	1 day