Liver Glycogen Dynamics
LGD
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this study is to investigate the effect of prolonged overnight fasting in the hepatic glycogen stores
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2020
CompletedFirst Posted
Study publicly available on registry
August 12, 2020
CompletedStudy Start
First participant enrolled
September 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2021
CompletedJune 2, 2021
May 1, 2021
8 months
August 10, 2020
May 31, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Hepatic glycogen content
Measured with 13C-MRS
1 hour
Secondary Outcomes (1)
Substrate oxidation
14 hours
Other Outcomes (7)
Intrahepatic fat content and composition (1H-MRS)
30 minutes
De novo lipogenesis (DNL)
20 hours
Hepatic fat oxidation
5 hours
- +4 more other outcomes
Study Arms (2)
Short overnight fast
EXPERIMENTALOvernight fasting duration intervention: Participants will receive their last evening meal at 11 pm and stay overnight fasted afterwards for (9.5h).
Long overnight fast
EXPERIMENTALOvernight fasting duration intervention: Participants will receive their last evening meal at 4.30 pm and stay overnight fasted afterwards for (16h).
Interventions
Subjects will adhere to overnight fasting protocol for 1 day
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University
Maastricht, Limburg, 6229ER, Netherlands
Study Officials
- PRINCIPAL INVESTIGATOR
Vera Schrauwen-Hinderling, Dr
Principal Investigator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 10, 2020
First Posted
August 12, 2020
Study Start
September 11, 2020
Primary Completion
May 21, 2021
Study Completion
May 21, 2021
Last Updated
June 2, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share