AzTrials
AzTrials

Metabolic SyndromeNCT05216796

Healthy Liver - Healthy Brain

A study testing Diet Intervention in people with Metabolic Syndrome and Non-Alcoholic Fatty Liver Disease, run by University of Texas at Austin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

People with liver disease report difficulties with attention and problem-solving skills. Diet plays an important role in the development of liver disease and/or pre-diabetes. The purpose of this study is to examine whether participation in a brief diet intervention (up to 3 weeks) can improve brain and liver health… Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
What is being tested?
Diet Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
18 May 2022to 1 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • at least 40 years of age
  • English speakers
  • show a minimum of 5% hepatic triglyceride level on liver imaging
  • have not taken part in a weight loss/dietary intervention within 6 months
  • not currently adhering to a low-carbohydrate diet (e.g., Atkins, Paleo)

Who cannot join

  • younger than 40 years of age
  • have a history of neurological disease (e.g. stroke, seizure disorder)
  • psychiatric illness (e.g. schizophrenia, bipolar disorder)
  • harmful alcohol use (AUDIT-C score >5)
  • morbid obesity (BMI>40)
  • MRI contraindications

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas at Austin

    Austin, Texas, 78712

Other trials in United States

About this study

Official title: Diet Intervention to Promote Liver and Brain Health in Adults With Non-alcoholic Fatty Liver Disease

People with liver disease report difficulties with attention and problem-solving skills. Diet plays an important role in the development of liver disease and/or pre-diabetes. The purpose of this study is to examine whether participation in a brief diet intervention (up to 3 weeks) can improve brain and liver health and function.

Read the detailed description

The importance of liver function for brain and cognitive health is undeniable. Specifically, adults with chronic liver diseases such as non-alcoholic fatty liver disease (NAFLD), a factor of metabolic syndrome (MetS), experience a range of symptoms including problems with attention, problem solving skills and executive function. Importantly, diet plays a role in the development of NAFLD. The investigators propose to be the first to demonstrate that Metabolic syndrome-related brain vulnerability, in the form of elevated free cerebral glutamate, is related to hepatic triglyceride level, through experimental manipulation of liver fat and multiorgan imaging. The investigators seek to improve liver health by altering diet content in a block randomized feeding trial. The investigators selected a low-carbohydrate (<30 g/d) diet (LoCHO) to reduce liver fat and a low-calorie (LoCAL) diet as a control for weight loss. The investigators hypothesize that LoCHO diet will improve cognitive performance by improving liver health and thus, brain health. This work may provide a way to support brain function in MetS and delay cognitive decline.

Being tested
Diet Intervention
Keywords
Neuroimaging, Liver, Low-carbohydrate, Diet
Medical subject headings
Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diet InterventionBehavioural

    Meal will be prepared and delivered by SNAP Kitchen, which has 7 locations in Austin and offers 20+ options for low-carbohydrate and low-calorie meals, each meal available in different sizes varying in energy intake. Meals will be entered into the Nutrition Data System for Research (NDS-R) software to confirm low-calorie profile. Meals will be delivered to participants' homes twice a week.

Study groups in NCT05216796
Study groupRoleWhat they receive
Low-carbohydrate dietExperimentalParticipants assigned to the Low-carbohydrate diet will be instructed to limit carbohydrate intake to <30 g/d.
Receives: Behavioral: Diet Intervention
Low-calorie dietActive comparatorParticipants assigned to the Low-calorie diet will be instructed to reduce their energy intake to match the LoCHO block (we are predicting ~1200 kcal/d for women and ~1500 kcal/d for men, following current recommendations for treatment of NAFLD).
Receives: Behavioral: Diet Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease in Liver Fat

    Hepatic triglyceride level will be assessed using liver 1H MRS.

    Measured: Liver fat will be measured at baseline (week 0) and after at least 2 weeks (up to 3 weeks) on the designated diet. The liver 1H MRS scans will happen during Visit 3 (baseline) and Visit 4 (at least 2 weeks on the diet).

  2. Decrease in cerebral gluatamate

    Cerebral glutamate levels will be measured using 1H MRS.

    Measured: Cerebral glutamate will be measured at baseline (week 0) and after at least 2 weeks (up to 3 weeks) on the designated diet. The brain 1H MRS scans will happen during Visit 3 (baseline) and Visit 4 (at least 2 weeks on the diet).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start18 May 2022
  3. Primary completion3 Aug 2024
  4. Study completion1 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
The investigators will employ a block randomization (n=10) between groups feeding trial where 100 participants will be assigned to receive either low-carbohydrate (LoCHO) or low-calorie (LoCAL) control diet for up to 3 weeks.
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05216796
Sponsor's protocol ID
STUDY00002189
Status last verified
Nov 2024
First submitted
30 Dec 2021
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Publications

  • Browning JD, Baker JA, Rogers T, Davis J, Satapati S, Burgess SC. Short-term weight loss and hepatic triglyceride reduction: evidence of a metabolic advantage with dietary carbohydrate restriction. Am J Clin Nutr. 2011 May;93(5):1048-52. doi: 10.3945/ajcn.110.007674. Epub 2011 Mar 2.

    PubMed 21367948

  • Ervin RB. Prevalence of metabolic syndrome among adults 20 years of age and over, by sex, age, race and ethnicity, and body mass index: United States, 2003-2006. Natl Health Stat Report. 2009 May 5;(13):1-7.

    PubMed 19634296

  • Haley AP, Gonzales MM, Tarumi T, Tanaka H. Subclinical vascular disease and cerebral glutamate elevation in metabolic syndrome. Metab Brain Dis. 2012 Dec;27(4):513-20. doi: 10.1007/s11011-012-9306-x. Epub 2012 May 3.

    PubMed 22552897

  • Oh R, Gilani B, Uppaluri KR. Low-Carbohydrate Diet. 2023 Aug 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537084/

    PubMed 30725769

  • Crabb DW, Im GY, Szabo G, Mellinger JL, Lucey MR. Diagnosis and Treatment of Alcohol-Associated Liver Diseases: 2019 Practice Guidance From the American Association for the Study of Liver Diseases. Hepatology. 2020 Jan;71(1):306-333. doi: 10.1002/hep.30866. No abstract available.

    PubMed 31314133

  • Wang T, Gallagher I, Park J, Li Y, Caillaud M, Alhalimi TA, Chen LS, McLaurin NN, Knight-Scott J, Browning JD, Haley AP, Tanaka H. The impact of short-term reduction in hepatic triglycerides on vascular health in adults with or at risk of metabolic dysfunction-associated steatotic liver disease. PLoS One. 2026 Aug 13;21(8):e0345338. doi: 10.1371/journal.pone.0345338. eCollection 2026.

    PubMed 42594065

  • Haley AP, Knight-Scott J, Caillaud M, Gallagher I, Park J, Li Y, Wang T, Tanaka H, Browning JD. Low carbohydrate and low-calorie diets reduce liver fat and lower brain glutamate and myo-inositol levels in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Metab Brain Dis. 2025 May 10;40(5):199. doi: 10.1007/s11011-025-01624-8.

    PubMed 40347387

Questions about this trial

What is this clinical trial studying?

A study testing Diet Intervention in people with Metabolic Syndrome and Non-Alcoholic Fatty Liver Disease, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in Liver Fat (time frame: Liver fat will be measured at baseline (week 0) and after at least 2 weeks (up to 3 weeks) on the designated diet. The liver 1H MRS scans will happen during Visit 3 (baseline) and Visit 4 (at least 2 weeks on the diet).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05216796, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in