Liver Glycogen Dynamics (LGD)

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

Study Overview

• Status: Completed
• Conditions: Hepatic Glycogen
• Intervention / Treatment: Behavioral: Overnight fasting duration

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229ER
      • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short overnight fast; Overnight fasting duration intervention: Participants will receive their last evening meal at 11 pm and stay overnight fasted afterwards for (9.5h).	Behavioral: Overnight fasting duration; Subjects will adhere to overnight fasting protocol for 1 day
Experimental: Long overnight fast; Overnight fasting duration intervention: Participants will receive their last evening meal at 4.30 pm and stay overnight fasted afterwards for (16h).	Behavioral: Overnight fasting duration; Subjects will adhere to overnight fasting protocol for 1 day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic glycogen content	Measured with 13C-MRS	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substrate oxidation	Measured as RQ	14 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrahepatic fat content and composition (1H-MRS)	Measured with 1H-MRS	30 minutes
De novo lipogenesis (DNL)	measured as percentage of palmitate in VLDL-TG originating from DNL	20 hours
Hepatic fat oxidation	measured as plasma BHB levels	5 hours
Liver volume	Measured with MRI	5 minutes
Substrate oxidation	measured with indirect calorimetry	30 minutes
Plasma metabolites related to energy metabolism	measured in plasma samples	5 hours
Body composition	fat mass/fat free mass measured with BodPod	5 minutes

Collaborators and Investigators

• Sponsor: Maastricht University
• Investigators: Principal Investigator: Vera Schrauwen-Hinderling, Dr, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Actual): May 21, 2021
• Study Completion (Actual): May 21, 2021

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: NL72118.068.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No