NCT04644887

Brief Summary

PNPLA3 rs738409 (I148M) variant is associated with hepatic liver accumulation and chronic liver diseases including non-alcoholic fatty liver disease. It has been shown that obesity augments genetic risk but studies investigating the interaction of PNPLA3 rs738409 risk variant and diet are scarce. The aim is to investigate the effect of dietary fat quality modification in participants with different variants of the PNPLA3 gene (rs738409). The primary outcome is the change in liver fat measured by magnetic resonance imaging in the randomized controlled 12-week dietary intervention trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

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

November 18, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 12, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

12 months

First QC Date

November 18, 2020

Last Update Submit

May 7, 2024

Conditions

Liver Fat

Keywords

humandietdietary fatliver fatgenotypenutrigenomics

Outcome Measures

Primary Outcomes (1)

  • Liver fat

    The primary outcome is the change in liver fat measured by magnetic resonance imaging

    12 weeks

Secondary Outcomes (10)

  • Hepatic condition monitored by ultrasound

    12 weeks

  • Hepatic condition monitored by elastography

    12 weeks

  • Hepatic condition monitored by calculated indexes

    12 weeks

  • Glucose metabolism

    12 weeks

  • Serum lipid profile

    12 weeks

  • +5 more secondary outcomes

Study Arms (4)

Healthy diet CC genotype

EXPERIMENTAL

The participants will follow the intervention diet during the 12-week intervention period.

Other: Dietary intervention: Healthy diet

Control diet CC genotype

ACTIVE COMPARATOR

The participants will follow the control diet during the 12-week intervention period.

Other: Dietary intervention: Control diet

Healthy diet GG genotype

EXPERIMENTAL

The participants will follow the intervention diet during the 12-week intervention period.

Other: Dietary intervention: Healthy diet

Control diet GG genotype

ACTIVE COMPARATOR

The participants will follow the control diet during the 12-week intervention period.

Other: Dietary intervention: Control diet

Interventions

Dietary intervention: Healthy dietOTHER

Dietary guidance in the intervention group is based on the Nordic and Finnish nutrition recommendations with an emphasis on the quality of dietary fat. The aims for the intake of fatty acids will be SFA \< 10 % of energy intake (E%) and mono- and polyunsaturated fatty acids (UFA) \>2/3 of the total fat intake. The key food products such as vegetable oil-based spread, liquid margarine and canola oil are provided to the participants. The participants are recommended to use fat free (e.g. milk, sourdough milk and yogurt) and low fat (e.g. cheese ≤ 17%) dairy products and low-fat meat, poultry, and fish as well as natural nuts and seeds.

Healthy diet CC genotypeHealthy diet GG genotype
Dietary intervention: Control dietOTHER

The control diet corresponds to the average nutrient intake in the Nordic countries, i.e. the intake of SFA about 15 E% and the proportion of UFA about 50 % of total fat intake. The participants of the control group will get butter-based spread for bread and cooking. They are recommended to use semi-skimmed milk (1,5 %), normal fat yogurt (\~2%), normal fat cheese (\~24-35 %) and avoid consumption of vegetable oils. They are allowed to eat a portion of fish and nuts once a week.

Control diet CC genotypeControl diet GG genotype

Eligibility Criteria

Age60 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen because the population source for recruitment Metabolic syndrome in men (METSIM) study is composed solely by men.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PNPLA3 rs738409, CC or GG
  • Body mass index (BMI) \< 35 kg/m2
  • Total cholesterol \< 8 mmol/l
  • LDL cholesterol \< 5 mmol/l
  • Fasting plasma glucose \< 7 mmol/l
  • Plasma alanine aminotransferase (ALT) \< 100 U/l
  • Age 60-75 y

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Public Health and Clinical Nutriton

Kuopio, Finland

Location

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Ursula Schwab, Professor

    University of Eastern Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The participants and investigators are blinded with the genotype, but not with the dietary groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 25, 2020

Study Start

January 12, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations

FI(1)