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Impact of Energy Density on Energy Intake During Bed Rest

NCT06571877 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-08-26

No results posted yet for this study

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 (+ 0.42 kcal/g 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 weight.The experiments are conducted during 4 campaigns, each campaign consisting of 12 participants.

Conditions

  • Bed Rest
  • Space Analogue

Interventions

OTHER

Dietary intervention with manipulation of the energy density

Dietary intervention with manipulation of the energy density either during breakfast or during lunch

Sponsors & Collaborators

  • DLR German Aerospace Center

    collaborator OTHER

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Isabelle Mack, PD Dr. · Internal Medicine VI, University Hospital Tuebingen, Osianderstr. 5, 72076 Tuebingen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-24
Primary Completion
2027-05-31
Completion
2027-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06571877 on ClinicalTrials.gov