Healthy Liver - Healthy Brain

The University of Texas System (UT)

Status: Completed

Conditions: Pre-diabetes; NAFLD; Non-Alcoholic Fatty Liver Disease; Metabolic Syndrome

Treatments: Behavioral: Diet Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05216796

STUDY00002189

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Low-carbohydrate diet

Experimental group

Description:

Participants assigned to the Low-carbohydrate diet will be instructed to limit carbohydrate intake to \<30 g/d.

Treatment:

Behavioral: Diet Intervention

Low-calorie diet

Active Comparator group

Description:

Participants 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).

Treatment:

Behavioral: Diet Intervention