NCT03593343

Brief Summary

Excessive fat in the liver is associated with impairments in metabolic health. Low levels of DNL and high levels of hepatic fat oxidation are considered to be protective. A decrease in glycogen stores has been causally linked to improved whole body fat oxidation. Also on an organ level, it is suggested that hepatic fat oxidation is stimulated by low hepatic glycogen stores. Next to hepatic fat oxidation, DNL may be influenced by hepatic glycogen stores. Some studies have shown that prolongation of fasting time lowers hepatic glycogen content. It is therefore hypothesized that prolonging fasting time will lower glycogen content and thereby increases fat oxidation and decreases DNL in the liver. To this end, hepatic fat oxidation (plasma marker beta-hydroxybutyrate), de novo lipogenesis, hepatic glycogen content and intrahepatic fat content, will be measured upon a short overnight fast and an extended overnight fast in 13 overweight/obese subjects with hepatic steatosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

July 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

January 8, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2020

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

July 10, 2018

Last Update Submit

October 2, 2020

Conditions

Fatty Liver, NonalcoholicMeal TimeFastingGlycogen Depletion

Outcome Measures

Primary Outcomes (1)

  • Hepatic fat oxidation

    measured as plasma BHB levels

    5 hours

Secondary Outcomes (1)

  • De novo lipogenesis (DNL)

    20 hours

Other Outcomes (5)

  • Hepatic glycogen content

    1 hour

  • Intrahepatic fat accumulation and composition

    20 minutes

  • Substrate oxidation

    30 minutes

  • +2 more other outcomes

Study Arms (2)

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).

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).

Behavioral: Overnight fasting duration

Interventions

Overnight fasting durationBEHAVIORAL

Subjects will adhere to overnight fasting protocol for 6 days

Long overnight fastShort overnight fast

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Caucasian (people will be excluded when having a ≥50% racial African/Asian background)
  • Male or postmenopausal female
  • Aged 45-75 years at start of the study
  • Body mass index (BMI) 27 - 38 kg/m2
  • Stable dietary habits (no weight loss or gain \>3kg in the past 3 months)
  • Sedentary lifestyle (not more than 2 hours of sports per week)
  • Liver fat ≥5% as determined by 1H-MRS

You may not qualify if:

  • Type 2 diabetes
  • Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other)
  • Contra-indication for MRI (which can be found in appendix II)
  • Alcohol consumption of \>2 servings per day
  • Regular smoking (\>5 cigarettes per day)
  • No use of medication interfering with investigated study parameters (as determined by responsible physician)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 ER, Netherlands

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseFasting

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesFeeding BehaviorBehavior

Study Officials

  • Vera Schrauwen-Hinderling, Dr

    Maastricht University Medical Center

    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
SPONSOR

Study Record Dates

First Submitted

July 10, 2018

First Posted

July 20, 2018

Study Start

January 8, 2019

Primary Completion

January 8, 2020

Study Completion

January 13, 2020

Last Updated

October 5, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)