Healthy Liver - Healthy Brain

NCT ID: NCT05216796

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2024-09-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Low-carbohydrate diet

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

Group Type: EXPERIMENTAL

Diet Intervention

Intervention Type: BEHAVIORAL

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.

Low-calorie diet

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).

Group Type: ACTIVE_COMPARATOR

Diet Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Diet 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Andreana P. Haley

Professor in Clinical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreana Haley, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychology, University of Texas at Austin

Locations

University of Texas at Austin

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21367948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19634296 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22552897 (View on PubMed)

Oh R, Gilani B, Uppaluri KR. Low-Carbohydrate Diet. 2023 Aug 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537084/

Reference Type: BACKGROUND

PMID: 30725769 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31314133 (View on PubMed)

Other Identifiers

STUDY00002189

Identifier Type: -

Identifier Source: org_study_id