Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571877
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Impact of Energy Density on Energy Intake During Bed Rest
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Energy Density on Energy Intake During Short- and Long-term Head-down Tilt Bed Rest in Healthy Participants
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ED-REST
Brief Summary:
Brief summary This study is conducted in the context of a 60 days strict bed-rest study with 6 head-down-tilt HDT body position Food intake can be challenging during bed-rest due to loss of appetite and constantly feeling full The study aims to assess whether or not energy intake varies during a meal when the energy density of a meal is increased by the fat content This experiment follows a crossover design with repeated measures within subjects The order of experimental conditions is balanced among participants and sex and the assignment of orders to participants is randomly On each test day participants are provided with breakfast lunch and dinner as usual Across test days the ED of breakfast 24 participants or lunch 24 participants is modified to two levels the standard level and an increased level 042 kcalg compared to the standard The meals are adjusted in energy density without noticeable changes in appearance or taste These meals have identical ingredients but the macronutrient proportions are modified Entrées with increased fat content are prepared by incorporating neutral-tasting vegetable oil into the standard recipes Participants receive their meals and are given the flexibility to eat ad libitum for 45 minutes To comply with the strict bed rest rules the next meal will be used for counterbalancing total energy intake over the day if necessary In case of problems a nutrient drink could be used to assure the requested total energy intake in order to maintain body weightThe experiments are conducted during 4 campaigns each campaign consisting of 12 participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None