Hepatic GlycogenLGDNCT04510155
Liver Glycogen Dynamics
A study testing Overnight fasting duration in people with Hepatic Glycogen, run by Maastricht University at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the effect of prolonged overnight fasting in the hepatic glycogen stores Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Glycogen
- What is being tested?
- Overnight fasting duration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Sep 2020to 21 May 2021
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are able to provide signed and dated written informed consent prior to any study specific procedures
- Caucasian (people will be excluded when having a ≥50% racial African/Asian background)
- Participants should have suitable veins for cannulation or repeated venipuncture
- Women are post-menopausal (defined as at least 1 year post cessation of menses)
- Men and women aged ≥ 45 and ≤ 75 years at the start of the study
- Body mass index (BMI) 18.5 - 25 kg/m2
- Stable dietary habits (no weight loss or gain >3kg in the past 3 months)
- Sedentary lifestyle (not more than 3 hours of vigorous sports per week)
Who cannot join
- Type 2 Diabetes Mellitus
- Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other)
- Any contraindication for MRI scanning
- Alcohol consumption of >2 servings per day
- Regular smoking
- No use of medication interfering with investigated study parameters (as determined by responsible physician)
- Participants who do not want to be informed about unexpected medical findings, or do not wish that their physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Liver Glycogen Dynamics and Substrate Oxidation in Lean Healthy Volunteers
The purpose of this study is to investigate the effect of prolonged overnight fasting in the hepatic glycogen stores
- Conditions
- Hepatic Glycogen
- Being tested
- Overnight fasting duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overnight fasting durationBehavioural
Subjects will adhere to overnight fasting protocol for 1 day
| Study group | Role | What they receive |
|---|---|---|
| Short overnight fast | Experimental | Overnight fasting duration intervention: Participants will receive their last evening meal at 11 pm and stay overnight fasted afterwards for (9.5h). Receives: Behavioral: Overnight fasting duration |
| Long overnight fast | Experimental | Overnight fasting duration intervention: Participants will receive their last evening meal at 4.30 pm and stay overnight fasted afterwards for (16h). Receives: Behavioral: Overnight fasting duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic glycogen content
Measured with 13C-MRS
Measured: 1 hour
Secondary outcomes (1)
Substrate oxidation
Measured as RQ
Measured: 14 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start11 Sep 2020
- Primary completion21 May 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic GlycogenStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Andriessen, Maastricht University
- Investigators
- Vera Schrauwen-Hinderling, Dr, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510155
- Sponsor's protocol ID
- NL72118.068.20
- Acronym
- LGD
- Status last verified
- May 2021
- First submitted
- 10 Aug 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Glycogen Dynamics and Substrate Oxidation in Lean Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04510155
- Acronym / sponsor ID
- LGD / NL72118.068.20
- Conditions
- Hepatic Glycogen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 12 Aug 2020 (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.
The purpose of this study is to investigate the effect of prolonged overnight fasting in the hepatic glycogen stores
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short overnight fast | Experimental | Behavioral: Overnight fasting durationOvernight fasting duration intervention: Participants will receive their last evening meal at 11 pm and stay overnight fasted afterwards for (9.5h). |
| Long overnight fast | Experimental | Behavioral: Overnight fasting durationOvernight fasting duration intervention: Participants will receive their last evening meal at 4.30 pm and stay overnight fasted afterwards for (16h). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants are able to provide signed and dated written informed consent prior to any study specific procedures
- Caucasian (people will be excluded when having a ≥50% racial African/Asian background)
- Participants should have suitable veins for cannulation or repeated venipuncture
- Women are post-menopausal (defined as at least 1 year post cessation of menses)
- Men and women aged ≥ 45 and ≤ 75 years at the start of the study
Key exclusion criteria (7 listed)
- Type 2 Diabetes Mellitus
- Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other)
- Any contraindication for MRI scanning
- Alcohol consumption of >2 servings per day
- Regular smoking
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 |
|---|---|---|
| Overnight fasting durationSubjects will adhere to overnight fasting protocol for 1 day | Behavioural | Long overnight fast, Short overnight fast |
Primary outcome
Hepatic glycogen content
Time frame: 1 hour
Measured with 13C-MRS
1 secondary outcome
Substrate oxidation
Time frame: 14 hours
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 2 Jun 2021.
- Individual participant dataSharing planned: No
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RecruitingObservational study
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Effects of Dual-Source Carbohydrate Intake and Liver Glycogen Repletion After Overnight Fasting.
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Non-invasive Assessment of Liver Fibrosis in a French Cohort of Pediatric Patients With Type III Glycogen Storage Disease: Current State and Perspectives
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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.
Vera Schrauwen-Hinderling, Dr principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overnight fasting duration in people with Hepatic Glycogen, run by Maastricht University 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 8 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 2 Jun 2021. 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?
Hepatic glycogen content (time frame: 1 hour). 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 2 Jun 2021; AzTrials last refreshed its copy on 31 Oct 2026.