Atrophy, DisuseNCT02521025
Bedrest, Feeding Pattern, and Insulin Sensitivity
A study testing Intermittent feeding pattern and Continuous feeding pattern in people with Atrophy, Disuse and Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In the present study, the investigators will assess the impact of two different feeding patterns (continuous vs intermittent) on insulin sensitivity and muscle mass following bedrest. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atrophy, Disuse, Insulin Resistance
- What is being tested?
- Intermittent feeding pattern and Continuous feeding pattern
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18.5 and 35
- Recreationally active
Who cannot join
- Type 2 diabetes
- Performing progressive resistance training in 6 months prior to study
- Back/knee/leg problems
- Hypertension
- Use of certain anticoagulants
- All co morbidities interacting with mobility and muscle metabolism of the lower limbs
- Blood donation in past 3 months
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center+
Maastricht, Limburg, 6229ER
About this study
Official title: The Impact of Continuous Versus Intermittent Feeding on Changes in Insulin Sensitivity During Bed-rest
In the present study, the investigators will assess the impact of two different feeding patterns (continuous vs intermittent) on insulin sensitivity and muscle mass following bedrest.
Read the detailed description
In the present study, the investigators will assess the impact of two different feeding patterns on insulin sensitivity and muscle mass following bedrest. Healthy, young males will be fed in a continuous (no breaks in food supply) or intermittent (in boluses throughout the day) manner.
- Conditions
- Atrophy, Disuse, Insulin Resistance
- Being tested
- Intermittent feeding pattern, Continuous feeding pattern
- Medical subject headings
- Muscular Disorders, Atrophic, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent feeding patternOther
Intermittent feeding
Continuous feeding patternOther
Continuous feeding
| Study group | Role | What they receive |
|---|---|---|
| Intermittent feeding | Experimental | Intermittent feeding pattern throughout the bedrest period, with 4 boluses per day Receives: Other: Intermittent feeding pattern |
| Continuous feeding | Experimental | Continuous feeding pattern throughout the bedrest period, with 4 boluses per day, without breaks in food supply. Receives: Other: Continuous feeding pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity (measured as glucose infusion rate during hyperinsulinaemic-euglycaemic clamp)
Measured: 7 days bedrest
Secondary outcomes (2)
Change in muscle mass (measured as upper leg muscle cross-sectional area with CT scan)
Via single-slice CT scan
Measured: 7 days bedrest
Change in lean tissue (measured via DEXA scan)
Via DEXA
Measured: 7 days bedrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrophy, DisuseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc van Loon, Principal investigator, Maastricht University Medical Centre+
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521025
- Sponsor's protocol ID
- MEC 15-3-035
- Status last verified
- Jul 2016
- First submitted
- 3 Aug 2015
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gonzalez JT, Dirks ML, Holwerda AM, Kouw IWK, van Loon LJC. Intermittent versus continuous enteral nutrition attenuates increases in insulin and leptin during short-term bed rest. Eur J Appl Physiol. 2020 Sep;120(9):2083-2094. doi: 10.1007/s00421-020-04431-4. Epub 2020 Jul 10.
PubMed 32651634Dirks ML, Miotto PM, Goossens GH, Senden JM, Petrick HL, van Kranenburg J, van Loon LJC, Holloway GP. Short-term bed rest-induced insulin resistance cannot be explained by increased mitochondrial H2 O2 emission. J Physiol. 2020 Jan;598(1):123-137. doi: 10.1113/JP278920. Epub 2019 Dec 26.
PubMed 31721213Dirks ML, Smeets JSJ, Holwerda AM, Kouw IWK, Marzuca-Nassr GN, Gijsen AP, Holloway GP, Verdijk LB, van Loon LJC. Dietary feeding pattern does not modulate the loss of muscle mass or the decline in metabolic health during short-term bed rest. Am J Physiol Endocrinol Metab. 2019 Mar 1;316(3):E536-E545. doi: 10.1152/ajpendo.00378.2018. Epub 2019 Jan 15.
PubMed 30645176
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Continuous Versus Intermittent Feeding on Changes in Insulin Sensitivity During Bed-rest
- ClinicalTrials.gov ID
- NCT02521025
- Acronym / sponsor ID
- MEC 15-3-035
- Conditions
- Atrophy, Disuse, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Aug 2015 (estimated)
- 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.
In the present study, the investigators will assess the impact of two different feeding patterns (continuous vs intermittent) on insulin sensitivity and muscle mass following bedrest.
Detailed description
In the present study, the investigators will assess the impact of two different feeding patterns on insulin sensitivity and muscle mass following bedrest. Healthy, young males will be fed in a continuous (no breaks in food supply) or intermittent (in boluses throughout the day) manner.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent feeding | Experimental | Other: Intermittent feeding patternIntermittent feeding pattern throughout the bedrest period, with 4 boluses per day |
| Continuous feeding | Experimental | Other: Continuous feeding patternContinuous feeding pattern throughout the bedrest period, with 4 boluses per day, without breaks in food supply. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI between 18.5 and 35
- Recreationally active
Key exclusion criteria (7 listed)
- Type 2 diabetes
- Performing progressive resistance training in 6 months prior to study
- Back/knee/leg problems
- Hypertension
- Use of certain anticoagulants
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 |
|---|---|---|
| Intermittent feeding patternIntermittent feeding | Other | Intermittent feeding |
| Continuous feeding patternContinuous feeding | Other | Continuous feeding |
Primary outcome
Change in insulin sensitivity (measured as glucose infusion rate during hyperinsulinaemic-euglycaemic clamp)
Time frame: 7 days bedrest
2 secondary outcomes
Change in muscle mass (measured as upper leg muscle cross-sectional area with CT scan)
Time frame: 7 days bedrest
Change in lean tissue (measured via DEXA scan)
Time frame: 7 days bedrest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Derived from this study: PubMed 32651634Gonzalez JT, Dirks ML, Holwerda AM, Kouw IWK, van Loon LJC. Intermittent versus continuous enteral nutrition attenuates increases in insulin and leptin during short-term bed rest. Eur J Appl Physiol. 2020 Sep;120(9):2083-2094. doi: 10.1007/s00421-020-04431-4. Epub 2020 Jul 10.
- Derived from this study: PubMed 31721213Dirks ML, Miotto PM, Goossens GH, Senden JM, Petrick HL, van Kranenburg J, van Loon LJC, Holloway GP. Short-term bed rest-induced insulin resistance cannot be explained by increased mitochondrial H2 O2 emission. J Physiol. 2020 Jan;598(1):123-137. doi: 10.1113/JP278920. Epub 2019 Dec 26.
- Derived from this study: PubMed 30645176Dirks ML, Smeets JSJ, Holwerda AM, Kouw IWK, Marzuca-Nassr GN, Gijsen AP, Holloway GP, Verdijk LB, van Loon LJC. Dietary feeding pattern does not modulate the loss of muscle mass or the decline in metabolic health during short-term bed rest. Am J Physiol Endocrinol Metab. 2019 Mar 1;316(3):E536-E545. doi: 10.1152/ajpendo.00378.2018. Epub 2019 Jan 15.
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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. This study is not recruiting at the moment.
Luc van Loon principal investigator
Maastricht University Medical Centre+
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent feeding pattern and Continuous feeding pattern in people with Atrophy, Disuse and Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 27 Jul 2016. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in insulin sensitivity (measured as glucose infusion rate during hyperinsulinaemic-euglycaemic clamp) (time frame: 7 days bedrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02521025, which also lists 3 linked publications.
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 27 Jul 2016.