Personalized diets for treatment of fatty liver and central obesity
| ISRCTN | ISRCTN86495943 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86495943 |
| Secondary identifying numbers | jyu-resd.172576021 |
- 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
Plain English Summary
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
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 |
| satu.p.pekkala@jyu.fi |
Scientific
Faculty of Sport and Health Sciences
Po. Box 35 (LL205)
Jyväskylä
40014
Finland
| ORCID ID |
0000-0002-0481-1957 |
|---|---|
| Phone | +358 408055162 |
| jukka.e.hintikka@jyu.fi |
Study information
| Study design | Single group controlled experimental study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Other, Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Personalized diet intervention to treat fatty liver and visceral adiposity |
| Study acronym | MAKSA |
| Study hypothesis | 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 |
| Condition | 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 | Change in liver fat, assessed with MRI at baseline (0), pre-intervention (4 wks), and post-intervention (16 wks) |
| Secondary outcome measures | 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) |
| Overall study start date | 01/01/2019 |
| Overall study end date | 01/06/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 49 |
| Participant 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) |
| Participant 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 |
| Recruitment start date | 01/01/2020 |
| Recruitment end date | 01/02/2020 |
Locations
Countries of recruitment
- Finland
Study participating centre
Jyvaskyla
40700
Finland
Sponsor information
Research council
Hakaniemenranta 6
PL 131
Jyväskylä
00531
Finland
| Phone | +358 29 533 5000 |
|---|---|
| kirjaamo@aka.fi | |
| Website | https://www.aka.fi/ |
"ROR" |
https://ror.org/05k73zm37 |
Funders
Funder type
Research council
Government organisation / Universities (academic only)
- Alternative name(s)
- Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
- Location
- Finland
Government organisation / Universities (academic only)
- Alternative name(s)
- Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
- Location
- Finland
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Finnish Foundation for Cardiovascular Research
- Location
- Finland
Results and Publications
| Intention to publish date | 01/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | First publication on cross-sectional data: 2023 (status: published doi.org/10.1128/mbio.02663-22) Longitudinal study results 2024 (in preparation) |
| 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 |
Editorial Notes
20/06/2024: Trial's existence confirmed by Ethics Committee of the Hospital District of Southwest Finland.
