Trial Outcomes & Findings for The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy. (NCT NCT04675775)

Results Overview

Overall participant retention rate based on proportion of participants who completed all study visits

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

up to 27 weeks post enrollment

Results posted on

2024-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Medically-tailored Meals Participants will receive meals that adhere to their specified nutritional targets dependent upon their cirrhosis complication of hepatic encephalopathy (HE) and/or ascites. Participants with HE will receive high-protein (approximately 1 gram of medication per kilogram of the body weight (1g/kg/day) and high-calorie (approximately 30c/kg/day) meals. Participants with HE and ascites will receive high-protein and high-calorie meals that are also low-sodium (less than or equal to 2000 milligrams a day). Medically-tailored meals (MTM): After the run-in baseline period participants will be expected to consume the meals and protein supplements meals between approximately Weeks 4 - 11 of the study. Additionally, participants will complete surveys before, during and after the meals. Protein supplements: A daytime and nighttime protein supplement will be provided after the baseline visit and should be consumed daily at home during the same study days as MTM. The daytime protein supplement is a protein bar (ZonePerfect or Perfect Bar). The nighttime supplement is a protein powder or liquid that can be dissolved in either water or milk. This is provided to participants with ProCel Vanilla Whey Protein powder which provides 15 grams of protein per serving or the ProCel LiquaCel liquid protein supplement mango, grape, watermelon and/or lemon flavors which provides 16g of protein per serving.
Overall Study STARTED	17
Overall Study Participants Who Did Not Withdraw Prior to MTM	12
Overall Study Participants Who Did Not Withdraw During MTM	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Medically-tailored Meals Participants will receive meals that adhere to their specified nutritional targets dependent upon their cirrhosis complication of hepatic encephalopathy (HE) and/or ascites. Participants with HE will receive high-protein (approximately 1 gram of medication per kilogram of the body weight (1g/kg/day) and high-calorie (approximately 30c/kg/day) meals. Participants with HE and ascites will receive high-protein and high-calorie meals that are also low-sodium (less than or equal to 2000 milligrams a day). Medically-tailored meals (MTM): After the run-in baseline period participants will be expected to consume the meals and protein supplements meals between approximately Weeks 4 - 11 of the study. Additionally, participants will complete surveys before, during and after the meals. Protein supplements: A daytime and nighttime protein supplement will be provided after the baseline visit and should be consumed daily at home during the same study days as MTM. The daytime protein supplement is a protein bar (ZonePerfect or Perfect Bar). The nighttime supplement is a protein powder or liquid that can be dissolved in either water or milk. This is provided to participants with ProCel Vanilla Whey Protein powder which provides 15 grams of protein per serving or the ProCel LiquaCel liquid protein supplement mango, grape, watermelon and/or lemon flavors which provides 16g of protein per serving.
Overall Study Withdrawal by Subject	7

Baseline Characteristics

The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medically-tailored Meals n=10 Participants Participants will receive meals that adhere to their specified nutritional targets dependent upon their cirrhosis complication of hepatic encephalopathy (HE) and/or ascites. Participants with HE will receive high-protein (approximately 1 gram of medication per kilogram of the body weight (1g/kg/day) and high-calorie (approximately 30c/kg/day) meals. Participants with HE and ascites will receive high-protein and high-calorie meals that are also low-sodium (less than or equal to 2000 milligrams a day). Medically-tailored meals (MTM): After the run-in baseline period participants will be expected to consume the meals and protein supplements meals between approximately Weeks 4 - 11 of the study. Additionally, participants will complete surveys before, during and after the meals. Protein supplements: A daytime and nighttime protein supplement will be provided after the baseline visit and should be consumed daily at home during the same study days as MTM. The daytime protein supplement is a protein bar (ZonePerfect or Perfect Bar). The nighttime supplement is a protein powder or liquid that can be dissolved in either water or milk. This is provided to participants with ProCel Vanilla Whey Protein powder which provides 15 grams of protein per serving or the ProCel LiquaCel liquid protein supplement mango, grape, watermelon and/or lemon flavors which provides 16g of protein per serving.
Age, Continuous	59.8 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants
Race/Ethnicity, Customized Non-white	1 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 27 weeks post enrollment

Overall participant retention rate based on proportion of participants who completed all study visits

Outcome measures

Outcome measures
Measure	Medically-tailored Meals n=17 Participants Participants will receive meals that adhere to their specified nutritional targets dependent upon their cirrhosis complication of hepatic encephalopathy (HE) and/or ascites. Participants with HE will receive high-protein (approximately 1 gram of medication per kilogram of the body weight (1g/kg/day) and high-calorie (approximately 30c/kg/day) meals. Participants with HE and ascites will receive high-protein and high-calorie meals that are also low-sodium (less than or equal to 2000 milligrams a day). Medically-tailored meals (MTM): After the run-in baseline period participants will be expected to consume the meals and protein supplements meals between approximately Weeks 4 - 11 of the study. Additionally, participants will complete surveys before, during and after the meals. Protein supplements: A daytime and nighttime protein supplement will be provided after the baseline visit and should be consumed daily at home during the same study days as MTM. The daytime protein supplement is a protein bar (ZonePerfect or Perfect Bar). The nighttime supplement is a protein powder or liquid that can be dissolved in either water or milk. This is provided to participants with ProCel Vanilla Whey Protein powder which provides 15 grams of protein per serving or the ProCel LiquaCel liquid protein supplement mango, grape, watermelon and/or lemon flavors which provides 16g of protein per serving.
Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits	10 Participants

PRIMARY outcome

Timeframe: up to 11 weeks post enrollment

The participant adherence rate to MTM based on proportion of participants who consumed ≥75% of delivered meals and evening snack

Outcome measures

Outcome measures
Measure	Medically-tailored Meals n=17 Participants Participants will receive meals that adhere to their specified nutritional targets dependent upon their cirrhosis complication of hepatic encephalopathy (HE) and/or ascites. Participants with HE will receive high-protein (approximately 1 gram of medication per kilogram of the body weight (1g/kg/day) and high-calorie (approximately 30c/kg/day) meals. Participants with HE and ascites will receive high-protein and high-calorie meals that are also low-sodium (less than or equal to 2000 milligrams a day). Medically-tailored meals (MTM): After the run-in baseline period participants will be expected to consume the meals and protein supplements meals between approximately Weeks 4 - 11 of the study. Additionally, participants will complete surveys before, during and after the meals. Protein supplements: A daytime and nighttime protein supplement will be provided after the baseline visit and should be consumed daily at home during the same study days as MTM. The daytime protein supplement is a protein bar (ZonePerfect or Perfect Bar). The nighttime supplement is a protein powder or liquid that can be dissolved in either water or milk. This is provided to participants with ProCel Vanilla Whey Protein powder which provides 15 grams of protein per serving or the ProCel LiquaCel liquid protein supplement mango, grape, watermelon and/or lemon flavors which provides 16g of protein per serving.
Participant Adherence Rate to Medically-Tailored Meals (MTM)	10 Participants

SECONDARY outcome

Timeframe: up to 27 weeks post enrollment

The number of participants who completed all study assessments and procedures during each study visit compared to the number of participants who did not complete all study assessments and procedures.

Outcome measures

Outcome measures
Measure	Medically-tailored Meals n=10 Participants Participants will receive meals that adhere to their specified nutritional targets dependent upon their cirrhosis complication of hepatic encephalopathy (HE) and/or ascites. Participants with HE will receive high-protein (approximately 1 gram of medication per kilogram of the body weight (1g/kg/day) and high-calorie (approximately 30c/kg/day) meals. Participants with HE and ascites will receive high-protein and high-calorie meals that are also low-sodium (less than or equal to 2000 milligrams a day). Medically-tailored meals (MTM): After the run-in baseline period participants will be expected to consume the meals and protein supplements meals between approximately Weeks 4 - 11 of the study. Additionally, participants will complete surveys before, during and after the meals. Protein supplements: A daytime and nighttime protein supplement will be provided after the baseline visit and should be consumed daily at home during the same study days as MTM. The daytime protein supplement is a protein bar (ZonePerfect or Perfect Bar). The nighttime supplement is a protein powder or liquid that can be dissolved in either water or milk. This is provided to participants with ProCel Vanilla Whey Protein powder which provides 15 grams of protein per serving or the ProCel LiquaCel liquid protein supplement mango, grape, watermelon and/or lemon flavors which provides 16g of protein per serving.
Proportion of Participants Who Completed All Study Assessments and Procedures	8 Participants

SECONDARY outcome

Timeframe: approximately 1 year (enrollment period)

Population: 30 individuals who were screened were determined to meet the eligibility criteria for this trial. Of those 30, 10 declined to participate and 3 did not participate for other reasons.

Results show the participants who enrolled in the trial following determination of the total number of candidates who were screened and determined to be eligible to participate in the trial.

Outcome measures

Outcome measures
Measure	Medically-tailored Meals n=30 Participants Participants will receive meals that adhere to their specified nutritional targets dependent upon their cirrhosis complication of hepatic encephalopathy (HE) and/or ascites. Participants with HE will receive high-protein (approximately 1 gram of medication per kilogram of the body weight (1g/kg/day) and high-calorie (approximately 30c/kg/day) meals. Participants with HE and ascites will receive high-protein and high-calorie meals that are also low-sodium (less than or equal to 2000 milligrams a day). Medically-tailored meals (MTM): After the run-in baseline period participants will be expected to consume the meals and protein supplements meals between approximately Weeks 4 - 11 of the study. Additionally, participants will complete surveys before, during and after the meals. Protein supplements: A daytime and nighttime protein supplement will be provided after the baseline visit and should be consumed daily at home during the same study days as MTM. The daytime protein supplement is a protein bar (ZonePerfect or Perfect Bar). The nighttime supplement is a protein powder or liquid that can be dissolved in either water or milk. This is provided to participants with ProCel Vanilla Whey Protein powder which provides 15 grams of protein per serving or the ProCel LiquaCel liquid protein supplement mango, grape, watermelon and/or lemon flavors which provides 16g of protein per serving.
Eligible Candidates Who Enrolled After Screening	17 Participants

SECONDARY outcome

Timeframe: up to 27 weeks

The percentage of enrolled participants who dropped out of either study stage before the final study visit due to withdrawal by participant or lost to follow-up, and not due to death, withdrawal by study staff or principal investigator discretion.

Outcome measures

Outcome measures
Measure	Medically-tailored Meals n=17 Participants Participants will receive meals that adhere to their specified nutritional targets dependent upon their cirrhosis complication of hepatic encephalopathy (HE) and/or ascites. Participants with HE will receive high-protein (approximately 1 gram of medication per kilogram of the body weight (1g/kg/day) and high-calorie (approximately 30c/kg/day) meals. Participants with HE and ascites will receive high-protein and high-calorie meals that are also low-sodium (less than or equal to 2000 milligrams a day). Medically-tailored meals (MTM): After the run-in baseline period participants will be expected to consume the meals and protein supplements meals between approximately Weeks 4 - 11 of the study. Additionally, participants will complete surveys before, during and after the meals. Protein supplements: A daytime and nighttime protein supplement will be provided after the baseline visit and should be consumed daily at home during the same study days as MTM. The daytime protein supplement is a protein bar (ZonePerfect or Perfect Bar). The nighttime supplement is a protein powder or liquid that can be dissolved in either water or milk. This is provided to participants with ProCel Vanilla Whey Protein powder which provides 15 grams of protein per serving or the ProCel LiquaCel liquid protein supplement mango, grape, watermelon and/or lemon flavors which provides 16g of protein per serving.
The Percentage of Enrolled Participants Who Dropped Out of Study	7 Participants

SECONDARY outcome

Timeframe: Up to 90 minutes

Feasibility of the assessments were evaluated by measuring the amount of time participants required to complete all assessments in minutes.

Outcome measures

Outcome measures
Measure	Medically-tailored Meals n=17 Participants Participants will receive meals that adhere to their specified nutritional targets dependent upon their cirrhosis complication of hepatic encephalopathy (HE) and/or ascites. Participants with HE will receive high-protein (approximately 1 gram of medication per kilogram of the body weight (1g/kg/day) and high-calorie (approximately 30c/kg/day) meals. Participants with HE and ascites will receive high-protein and high-calorie meals that are also low-sodium (less than or equal to 2000 milligrams a day). Medically-tailored meals (MTM): After the run-in baseline period participants will be expected to consume the meals and protein supplements meals between approximately Weeks 4 - 11 of the study. Additionally, participants will complete surveys before, during and after the meals. Protein supplements: A daytime and nighttime protein supplement will be provided after the baseline visit and should be consumed daily at home during the same study days as MTM. The daytime protein supplement is a protein bar (ZonePerfect or Perfect Bar). The nighttime supplement is a protein powder or liquid that can be dissolved in either water or milk. This is provided to participants with ProCel Vanilla Whey Protein powder which provides 15 grams of protein per serving or the ProCel LiquaCel liquid protein supplement mango, grape, watermelon and/or lemon flavors which provides 16g of protein per serving.
Time Required to Complete Assessments	43.27 minutes Standard Deviation 21.44

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 11 weeks post enrollment

The proportion of participants who complete all 24-hour Diet Recall interviews compared to the number of participants who did not complete all 24-Hour Diet Recall interviews.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, up to 13 weeks

This was a computerized, timed test of attention conducted on an Interactive Personal Application Device (iPad) or smart device by a phone application that asked participants to identify the color of words. The score was the sum of the time it took to complete color-word concordance and color-word discordance. A score of less than 190 was considered 'normal' cognitive function. Participants who were color-blind were excluded from performing this test.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, up to 27 weeks

The participants listed as many unique animals as possible in 60 seconds.

Outcome measures

Outcome data not reported

Adverse Events

Medically-tailored Meals

Serious events: 5 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Medically-tailored Meals n=17 participants at risk Participants will receive meals that adhere to their specified nutritional targets dependent upon their cirrhosis complication of hepatic encephalopathy (HE) and/or ascites. Participants with HE will receive high-protein (approximately 1 gram of medication per kilogram of the body weight (1g/kg/day) and high-calorie (approximately 30c/kg/day) meals. Participants with HE and ascites will receive high-protein and high-calorie meals that are also low-sodium (less than or equal to 2000 milligrams a day). Medically-tailored meals (MTM): After the run-in baseline period participants will be expected to consume the meals and protein supplements meals between approximately Weeks 4 - 11 of the study. Additionally, participants will complete surveys before, during and after the meals. Protein supplements: A daytime and nighttime protein supplement will be provided after the baseline visit and should be consumed daily at home during the same study days as MTM. The daytime protein supplement is a protein bar (ZonePerfect or Perfect Bar). The nighttime supplement is a protein powder or liquid that can be dissolved in either water or milk. This is provided to participants with ProCel Vanilla Whey Protein powder which provides 15 grams of protein per serving or the ProCel LiquaCel liquid protein supplement mango, grape, watermelon and/or lemon flavors which provides 16g of protein per serving.
Hepatobiliary disorders Exacerbation of cirrhosis	29.4% 5/17 • up to 27 weeks

Other adverse events

Adverse event data not reported

Additional Information

Elliot Tapper

University of Michigan

Phone: 734-647-9252

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place