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Healthy Liver - Healthy Brain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05216796
Enrollment
55
Registered
2022-02-01
Start date
2022-05-18
Completion date
2024-09-01
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, NAFLD, Non-Alcoholic Fatty Liver Disease, Pre-diabetes

Keywords

Neuroimaging, Liver, Low-carbohydrate, Diet

Brief 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 and function.

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.

Interventions

BEHAVIORALDiet Intervention

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.

Sponsors

University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Decrease in Liver FatLiver 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).Hepatic triglyceride level will be assessed using liver 1H MRS.
Decrease in cerebral gluatamateCerebral 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).Cerebral glutamate levels will be measured using 1H MRS.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026