Liver Glycogen Dynamics

NCT ID: NCT04510155

Last Updated: 2021-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-11

Study Completion Date

2021-05-21

Brief Summary

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

Detailed Description

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Conditions

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Hepatic Glycogen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Overnight fasting duration

Intervention Type BEHAVIORAL

Subjects will adhere to overnight fasting protocol for 1 day

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).

Group Type EXPERIMENTAL

Overnight fasting duration

Intervention Type BEHAVIORAL

Subjects will adhere to overnight fasting protocol for 1 day

Interventions

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Overnight fasting duration

Subjects will adhere to overnight fasting protocol for 1 day

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University

OTHER

Sponsor Role lead

Responsible Party

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Charlotte Andriessen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vera Schrauwen-Hinderling, Dr

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

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Maastricht University

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL72118.068.20

Identifier Type: -

Identifier Source: org_study_id

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