Factors That Determine the Responses to Food Ingestion: Protein Load

NCT06139237 | Unknown

• 1 other identifier: PR(AG)338/2016P
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Arms (2)

High-protein supplement

EXPERIMENTAL

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).

Other: High-protein supplement

Balanced supplement

ACTIVE COMPARATOR

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)

Other: Balanced supplement

Interventions

High-protein supplement OTHER

High protein supplement 200 mL

High-protein supplement

Balanced supplement OTHER

Balanced supplement 200 mL

Balanced supplement

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-obese

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Central Study Contacts

Fernando Azpiroz, MD

CONTACT

+34932746259; azpiroz.fernando@gmail.com

Gloria Santaliestra

CONTACT

gloria.santaliestra@vhir.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: November 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

ES (1)