Liver Glycogen Dynamics

Not Applicable

Completed

• Conditions: Hepatic Glycogen
• Interventions: Behavioral: Overnight fasting duration

• Registration Number: NCT04510155
• Lead Sponsor: Maastricht University

Brief Summary

The purpose of this study is to investigate the effect of prolonged overnight fasting in the hepatic glycogen stores

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Study Start: 2020-09-11
• Status Verified: 2021-05
• Primary Completion: 2021-05-21
• Study Completion: 2021-05-21
• Last Update Submitted: 2021-05-31
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Long overnight fast	Overnight fasting duration	Overnight fasting duration intervention: Participants will receive their last evening meal at 4.30 pm and stay overnight fasted afterwards for (16h).
Short overnight fast	Overnight fasting duration	Overnight fasting duration intervention: Participants will receive their last evening meal at 11 pm and stay overnight fasted afterwards for (9.5h).

Primary Outcome Measures

Name	Time	Method
Hepatic glycogen content	1 hour	Measured with 13C-MRS

Secondary Outcome Measures

Name	Time	Method
Substrate oxidation	14 hours	Measured as RQ

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Limburg, Netherlands