Impact of Energy Density on Energy Intake During Bed Rest

NCT06571877 | Enrolling By Invitation

• 1 other identifier: 50WB2426A
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 (+ 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

Keywords

energy intake; energy density; satiety

Outcome Measures

Primary Outcomes (1)

• 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

  Measurments taken at days 6, 8, 51 and 53 in the 60 days head down tilt period.

Secondary Outcomes (5)

• Amount of food intake in g

  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)

  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

  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

  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

  Allocation to countermeasure test arms is done ahead of the bed rest study, at least 4 weeks ahead bed rest.

Study Arms (2)

Control energy density condition

EXPERIMENTAL

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

High energy density condition

EXPERIMENTAL

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

Interventions

Dietary intervention with manipulation of the energy density OTHER

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

Control energy density condition; High energy density condition

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physically and mentally healthy test subjects that declare their willingness to participate in the entire study and successfully pass the psychological and medical screening
• Aged between 24 and 55 years
• Body mass index between 18 to 28 kg/m2
• Body height between 153 to 190 cm (+/- 2 cm)
• Signed informed consent
• Demonstrable medical insurance and official certificate of absence of criminal record
• No less than 2 SD below the average normal bone mineral density (measured by dual-energy x-ray absorptiometry) for hip and lumbar spine (i.e., mean peak bone mineral density of Caucasian, sex-matched young adults) denoted by T-score (T-score \> -2)
• Demonstrable dentist certificate
• Hormonal contraception for female participants is allowed, but details (manufacturer, doses, dates) must be reported

You may not qualify if:

• Any infectious, genetic, autoimmune, endocrinological, hematological, cardiovascular, lung, gastroenterological, kidney, rheumatic, muscle, bone, orthopedic, dermatological, gynecological, urological, ophthalmological, otorhinolaryngological, neurological or psychiatric disease (see at the end of document; a) that precludes a safe participation in the study or might significantly impact scientific results of the study according to the study physician
• Drug, medication or alcohol abuse (regular consumption of more than 30 g alcohol/day)
• Smoker within 6 months prior to enrollment
• Any long-term medication use that might significantly impact scientific results of the study (for instance bisphosphonate therapy, anti-hypertensives, gastro-esophageal reflux).
• Special dietary requests, that cannot be provided by the project team (e.g. vegan, vegetarian or other ineligible diet)
• Claustrophobia
• Increased intraocular pressure
• Hyperopia / Myopia \> +/- 5.0 Diopters
• Astigmatism \> 3 Diopters
• History of laser surgery of the eye, glaucoma and retinal surgery
• Any ocular condition that would significantly impact visual function
• Significant chronic gastro-esophageal reflux precluding a safe participation in the study
• Clinically relevant allergy (e.g. requirement to carry a stand-by emergency injection), that precludes a safe participation in the study
• History of chronic back complaints, that precludes a safe participation in the study
• History of kidney stones

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• DLR German Aerospace Center: collaborator

Study Sites (1)

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Isabelle Mack, PD Dr.

  Internal Medicine VI, University Hospital Tuebingen, Osianderstr. 5, 72076 Tuebingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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. It can be not ruled out that some participants may recognize differences of the meals.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Head for Nutrition and Weight Regulation

Model Details: This is a repeated measures randomized controlled cross-over design with an additional randomization on block: 1\) Randomized controlled cross-over experiments are conducted at the end of the first week of the bedrest (days 6-8) and at the end of the bed rest (days 51-53). In total, every participant is tested on 4 days, receiving either the control test meal or the meal with increased fat content in a 1000 ml bowl. 2) Additionally, the 4 campaigns are randomized on block so that either the breakfast or the lunch will be manipulated.

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 26, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)