Bed RestED-RESTNCT06571877
Impact of Energy Density on Energy Intake During Bed Rest
A study testing Dietary intervention with manipulation of the energy density in people with Bed Rest and Space Analogue, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Bed Rest, Space Analogue
- What is being tested?
- Dietary intervention with manipulation of the energy density
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- 24 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Candidate subject exclusion criteria for the study will include the following:
- 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)
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- 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
- Anemia: Hemoglobin under normal values (see at the end of document; b). (Normal values of Hemoglobin for men: 13.0-17.5 g/dl; women 12.0-16.0 g/dl)
- Elevated risk of thrombosis (see at the end of document; c)
- Inability to successfully complete a 10-minute upright posture test without clinically relevant orthostatic symptoms
- Current or history of hemorrhagic diathesis or coagulations disorders
- History of spinal cord disease, including radiculopathy, myelopathy, or neuropathy
- History of disorders affecting CSF circulation (i.e. hydrocephalus, idiopathic intracranial hypertension) History of more than one depressive episode and/or history of a severe depressive episode, such as requiring inpatient or intensive outpatient treatment
- Known chronic tinnitus
- Hearing loss (bi-lateral or one-sided) precluding successful participation in the study
- Female candidate is pregnant or breast-feeding
- Female candidate is in menopause or post-menopause, unless on hormone replacement therapy (but not treated with bisphosphonates or anti-resorptives)
- Female candidate stopped hormonal contraception medication up to 3 months prior to study start
- Metal implants (or objects like metallic slivers in the eyes, or bullets or shrapnel in the body) or other kinds of bone synthesis materials, implanted medical devices, tattoos or permanent make-up incompatible with MRI
- Participation in a (clinical) study within the last 3 months before start of this study that significantly confounds participation in the study Any other condition which makes the test subject unsuitable for study inclusion in the opinion of the project team
- Explanations to exclusion criteria (a-c)
- History of single episode of prolonged grief or mild depression with no symptoms in the 12 months prior to study start is acceptable
- Normal values from: https://www.lab-quade.de/leistungen/?idLoc=1
- A thrombosis risk stratification will be conducted according to clinical standards: in the anamnesis, the subject will be extensively questioned for thrombosis risk factors and assessed by means of specific analytical laboratory methods for assessing thrombosis risk using thrombophilia screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Impact of Energy Density on Energy Intake During Short- and Long-term Head-down Tilt Bed Rest in Healthy Participants
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
- Being tested
- Dietary intervention with manipulation of the energy density
- Keywords
- energy intake, energy density, satiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention with manipulation of the energy densityOther
Dietary intervention with manipulation of the energy density either during breakfast or during lunch
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Dietary intervention with manipulation of the energy density |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The amount of food intake is calculated by measuring the amount of food before and after the experiment
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Allocation to countermeasure test arms is done ahead of the bed rest study, at least 4 weeks ahead bed rest.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start24 Sep 2024 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bed RestStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- DLR German Aerospace Center
- Responsible party
- Principal investigator, Dr. Isabelle Mack, University Hospital Tuebingen
- Investigators
- Isabelle Mack, PD Dr., Principal investigator, Internal Medicine VI, University Hospital Tuebingen, Osianderstr. 5, 72076 Tuebingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571877
- Sponsor's protocol ID
- 50WB2426A
- Acronym
- ED-REST
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Energy Density on Energy Intake During Short- and Long-term Head-down Tilt Bed Rest in Healthy Participants
- ClinicalTrials.gov ID
- NCT06571877
- Acronym / sponsor ID
- ED-REST / 50WB2426A
- Conditions
- Bed Rest, Space Analogue
- Keywords
- energy intake, energy density, satiety
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- DLR German Aerospace Center
- Study start
- 24 Sep 2024 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control energy density condition | Experimental | Other: Dietary intervention with manipulation of the energy densityEach 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. |
| High energy density condition | Experimental | Other: Dietary intervention with manipulation of the energy densityParticipants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (33 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intervention with manipulation of the energy densityDietary intervention with manipulation of the energy density either during breakfast or during lunch | Other | Control energy density condition, High energy density condition |
Primary outcome
Energy intake in kcal
Time frame: Measurments taken at days 6, 8, 51 and 53 in the 60 days head down tilt period.
Energy intake is calculated by measuring the amount of food before and after the experiment and precalculation of the energy content of the meals
5 secondary outcomes
Amount of food intake in g
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)
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
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
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
Time frame: Allocation to countermeasure test arms is done ahead of the bed rest study, at least 4 weeks ahead bed rest.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle Mack, PD Dr. principal investigator
Internal Medicine VI, University Hospital Tuebingen, Osianderstr. 5, 72076 Tuebingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention with manipulation of the energy density in people with Bed Rest and Space Analogue, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake in kcal (time frame: Measurments taken at days 6, 8, 51 and 53 in the 60 days head down tilt period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.