An interventional study of Dietary intervention with manipulation of the energy density in Bed Rest and Space Analogue, sponsored by University Hospital Tuebingen. Enrolling by invitation at 1 site in Germany. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Basic science
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.
University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.
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Exclusion Criteria:
Candidate subject exclusion criteria for the study will include the following:
Special dietary requests, that cannot be provided by the project team (e.g. vegan, vegetarian or other ineligible diet)
Explanations to exclusion criteria (a-c)
Each participant is its own control (cross-over design). Participants receive a bowl with 1000 ml food content consisting of oats, apple pie, grated nuts and milk having an energy density of 1,42 kcal/g. The participants are allowed to eat ad libitum for 45 minutes.
Other: Dietary intervention with manipulation of the energy density
Participants receive a bowl with 1000 ml food content consisting of oats, apple pie, grated nuts, milk and neutral-tasting vegetable oil having an energy density of 1,84 kcal/g.The participants are allowed to eat ad libitum for 45 minutes.
Other: Dietary intervention with manipulation of the energy density
Dietary intervention with manipulation of the energy density either during breakfast or during lunch
Energy intake in kcal
Energy intake is calculated by measuring the amount of food before and after the experiment and precalculation of the energy content of the meals
Time frame: Measurments taken at days 6, 8, 51 and 53 in the 60 days head down tilt period.
Amount of food intake in g
The amount of food intake is calculated by measuring the amount of food before and after the experiment
Time frame: Measurments taken at days 6, 8, 51 and 53 in the 60 days head down tilt period.
Composite appetite score measured by 10 cm visual analogue scales (VAS)
Appetite perception is measured using validated 100 mm VAS for hunger, satisfaction, fullness, and prospective food consumption (Flint et al., 2000). The composite score is calculated as follows: (\[hunger + prospective food consumption + (100-fullness) + (100-satisfaction)\]/4) by Stubbs et al., 2000
Time frame: Measurments taken at days 6, 8, 51 and 53 in the 60 days head down tilt period before the meal, 30 minutes, 45 minutes and 60 minutes after the meal and directly before the next meal (either lunch or dinner)
Visual analogue scale for perception of portion size
Portion size is measured using a 100 mm VAS.
Time frame: Measurments taken at days 6, 8, 51 and 53 in the 60 days head down tilt period before the meal, 30 minutes, 45 minutes and 60 minutes after the meal and directly before the next meal (either lunch or dinner)
Emotional response
Emotional response is used using the Self assessment manikin (Bradley \& Lang, 1994)
Time frame: Measurments taken at days 6, 8, 51 and 53 in the 60 days head down tilt period before the meal, 30 minutes and 60 minutes after the meal and directly before the next meal (either lunch or dinner)
Number of participants assigned to countermeasures for consequences of long-term bed rest
During bed rest, the participants are allocated to 4 arms of different countermeasures for consequences of long-term bed red which is independent of this food study. These countermeasures include: Arm 1: Electrical Muscle Stimulation; Arm 2: Proprioceptive Training; Arm 3: Exercise plus proprioceptive Training; Arm 4: Control. This information on "bed rest countermeasure" will be added as a co-variate.
Time frame: Allocation to countermeasure test arms is done ahead of the bed rest study, at least 4 weeks ahead bed rest.
Plan to share: No
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