Healthy Liver - Healthy Brain

NCT05216796 | Completed

• 1 other identifier: STUDY00002189
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Neuroimaging; Liver; Low-carbohydrate; Diet

Outcome Measures

Primary Outcomes (2)

• Decrease in Liver Fat

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

  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).

• Decrease in cerebral gluatamate

  Cerebral glutamate levels will be measured using 1H MRS.

  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).

Study Arms (2)

Low-carbohydrate diet

EXPERIMENTAL

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

Behavioral: Diet Intervention

Low-calorie diet

ACTIVE COMPARATOR

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).

Behavioral: Diet Intervention

Interventions

Diet Intervention 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; Low-carbohydrate diet

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (5)

• 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.

  PMID: 21367948 BACKGROUND

• 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.

  PMID: 19634296 BACKGROUND

• 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.

  PMID: 22552897 BACKGROUND

• 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/

  PMID: 30725769 BACKGROUND

• 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.

  PMID: 31314133 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Non-alcoholic Fatty Liver Disease; Glucose Intolerance

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Hyperglycemia

Study Officials

• Andreana Haley, PhD

  Department of Psychology, University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Clinical Psychology

Model Details: 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.

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: February 1, 2022
• Study Start: May 18, 2022
• Primary Completion: August 3, 2024
• Study Completion: September 1, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)