Personalized diets for treatment of fatty liver and central obesity

ISRCTN	ISRCTN86495943
DOI	https://doi.org/10.1186/ISRCTN86495943
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	jyu-resd.172576021
Sponsor	Academy of Finland
Funders	Research Council of Finland, Juho Vainio Foundation, Sydäntutkimussäätiö

Submission date: 20/06/2024
Registration date: 26/06/2024
Last edited: 25/06/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Dietary interventions are a new and promising way to treat hepatic steatosis, which is the buildup of fat in the liver, and visceral adiposity, which is the buildup of fat around the central organs in the body.

One type of dietary treatment involves prebiotics. Prebiotics are types of fiber and resistant carbohydrates that affect the gut microbiome. The gut microbiome consists of trillions of bacteria, yeast, and other microbes living in the intestine.

Our research focuses on the potential of xylo-oligosaccharides (XOS), a type of fiber, to treat these conditions. We also study how this prebiotic affects the gut microbiome and identify who might benefit the most from these interventions.

Who can participate?
Our study recruited overweight or obese adults aged 18 - 75 years

What does the study involve?
Participants ingest a dose of XOS daily for four months, preceded by 1 month without XOS. We measured their body composition and liver fat content in three time points and also collected blood and fecal samples to study the gut microbiome.

What are the possible benefits and risks of participating?
Participants receive potential health benefits from the dietary intervention and receive comprehensive information about their health and wellbeing. A possible adverse effect of XOS is gastrointestinal distress. Participants are inquired about adverse effects weekly and can opt out at any time.

Where is the study run from?
Research Council of Finland

When is the study starting and how long is it expected to run for?
January 2019 to June 2020

Who is funding the study?
Research Council of Finland
Juho Vainio Foundation (Finland)
Sydäntutkimussäätiö (The Finnish Foundation for Cardiovascular Research)

Who is the main contact?
satu.p.pekkala@jyu.fi
jukka.e.hintikka@jyu.fi

Contact information

Dr Satu Pekkala
Public, Principal investigator

Faculty of Sport and Health Sciences
Po. Box 35 (LL225)
Jyvaskyla
40014
Finland

ORCID ID	0000-0003-3107-0813
Phone	+358 453582898
Email	satu.p.pekkala@jyu.fi

Mr Jukka Hintikka
Scientific

Faculty of Sport and Health Sciences
Po. Box 35 (LL205)
Jyväskylä
40014
Finland

ORCID ID	0000-0002-0481-1957
Phone	+358 408055162
Email	jukka.e.hintikka@jyu.fi

Study information

Primary study design	Interventional
Study design	Single group controlled experimental study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Personalized diet intervention to treat fatty liver and visceral adiposity
Study acronym	MAKSA
Study objectives	XOS intervention manipulates the gut microbiome and benefits hepatic health in overweight responsive individuals
Ethics approval(s)	Approved 27/11/2019, Ethics Committee of the Hospital District of Southwest Finland (P.O. Box 52, Turku, 20251, Finland; +358 504383708; eettinen.toimikunta@varha.fi), ref: ETMK 72/2019
Health condition(s) or problem(s) studied	Overweight, non-alcoholic fatty liver disease
Intervention	Prebiotic nutritional supplementation: xylo-oligosaccharides 2.8 g daily in powder form. Each participant went through a 1-month control period, followed by 4 months of dietary intervention.
Intervention type	Supplement
Primary outcome measure(s)	Change in liver fat, assessed with MRI at baseline (0), pre-intervention (4 wks), and post-intervention (16 wks)
Key secondary outcome measure(s)	1. Responses in gut microbial composition or diversity, measured with 16S rRNA sequencing at baseline (0), pre-intervention (4 wks), and post-intervention (16 wks) 2. Determinants of response to the prebiotic, measured with microbiome, metabolome, GWAS at baseline (0), pre-intervention (4 wks), and post-intervention (16 wks)
Completion date	01/06/2020

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	50
Total final enrolment	49
Key inclusion criteria	1. Age 18<75 years 2. Being overweight (body mass index [BMI] >25 kg/m² 3. High waist circumference (>102 cm for males, >88 cm for females)
Key exclusion criteria	1. Antibiotic treatment 1 month prior to the study 2. Excessive alcohol consumption (>20 g/day for females, 30 g/day for males) 3. Inflammatory bowel disease 4. Celiac disease 5. Major eating disorders 6. Hypothyroidism
Date of first enrolment	01/01/2020
Date of final enrolment	01/02/2020

Locations

Countries of recruitment

Finland

Study participating centre

University of Jyvaskyla, Faculty of Sport and Health Sciences

Rautpohjankatu 8
Jyvaskyla
40700
Finland

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Restricted use due to personal information protection. You can still contact author to ask for a copy of the material. Metadata for the project is shared at https://doi.org/10.17011/jyx/dataset/85068

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Interim results article		30/01/2023	20/06/2024	Yes	No
Other unpublished results			20/06/2024	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/06/2024: Trial's existence confirmed by Ethics Committee of the Hospital District of Southwest Finland.