- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07678567
Pomegranate Dietary Supplements in AUD and ALD
Supplementation of Pomegranate Dietary Supplements and Characterization of Urolithin Metabotypes in Patients With Alcohol Use Disorder (AUD) and Alcohol-associated Liver Disease (ALD)
연구 개요
상태
상세 설명
A large body of anecdotal evidence suggests beneficial effects for many botanical dietary supplements (BDS) on human health. The U.S. alone spent ~$7.5 billion on BDS in 2016, suggesting significant interest in the consumption of such products. Since ancient times, pomegranate has been known as a 'healing food', with numerous health benefits, including prevention of health risk factors for high blood pressure, arthritis, high cholesterol, oxidative stress, and hyperglycemia (1-4). Despite reported benefits from consumption of pomegranate dietary supplements (PDS), the overall outcomes of clinical trials were not uniform, and the results were inconclusive (5-7). However, gut microbial metabolites derived from polyphenolics of pomegranate have been shown to promote many beneficial activities, including anti-oxidative and anti-inflammatory activities (8- 12). Thus, the inter-individual variation in human gut microbiota compositions and their metabolic capacities may hamper the predicted PDS-mediated benefits. We postulate that harboring the specific gut microbiota responsible for metabolizing PDS into beneficial metabolites is critical to manifesting the complete benefits of PDS consumption. Recently, we reported one such microbial metabolite, 'urolithin A' (UroA), derived from ellagic acid-rich diets (e.g., pomegranate), significantly enhanced gut barrier function in addition to blocking unwarranted inflammation in colitis models (13) and protected from alcoholic liver disease (ALD) in mouse models (unpublished data). UroA is produced only in 40-50% of humans, who harbor the appropriate microbiota capable of converting consumed ellagic acid-rich diets (such as pomegranates, berries, and walnuts). UroA levels varied significantly among populations, to micromolar levels in some individuals. The direct correlations between UroA levels and human health/disease conditions are not yet available.
This project aims to determine an individual's ability to generate active gut microbial metabolites called urolithins upon consumption of pomegranate dietary supplements. We, and others, reported that urolithins are the major active metabolites that are responsible for the beneficial activities that are rendered from eating pomegranates, berries, or walnuts. However, the production of urolithins from the parent compound ellagic acid (EA) is dependent upon the presence of certain bacteria in the human gut. In this trial, we propose to investigate variations in gut microbiota and their capacity to metabolize pomegranate dietary supplements (PDS) into active urolithins. We will measure the levels of urolithins in blood as well as inflammatory cytokines in plasma samples upon consumption of PDS.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Vatsalya Vatsalya, MD
- 전화번호: 502-852-8928
- 이메일: v0vats01@louisville.edu
연구 연락처 백업
- 이름: Venkatakrishna R Jala, PhD
- 전화번호: 502-852-5523
- 이메일: jvrao001@louisville.edu
연구 장소
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Kentucky
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Louisville, Kentucky, 미국, 40202
- University of Louisville
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수석 연구원:
- Craig J McClain, M.D.
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수석 연구원:
- Vatsalya Vatsalya, M.D.
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수석 연구원:
- Ventakrishna R Jala, Ph.D.
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연락하다:
- Vatsalya Vatsalya, M.D.
- 전화번호: 502-852-8928
- 이메일: v0vats01@louisville.edu
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연락하다:
- Steve Mahanes, M.S.
- 전화번호: 502-852-1388
- 이메일: steve.mahanes@louisville.edu
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Healthy Group:
Inclusion: Healthy individuals, Exclusion: AUD, ALD, AC, and inflammatory conditions,
Alcohol Use Disorder Group:
Inclusion: AUD diagnosis Exclusion: alcohol-associated systemic conditions
Alcohol-associated liver disease Group:
Inclusion: early-stage ALD comorbid with AUD Exclusion: Only AUD or AUD with AC
Alcohol-associated cirrhosis Inclusion: AC with AUD Exclusion: AUD, and early stage ALD, as well as determined by the study cohort criteria
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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healthy volunteers
Adults ≥18, Drink no alcohol or drink < 50 grams of alcohol per day on average if female and < 80 grams per day on average if male; 3 capsules of the PDS (pomegranate dietary supplement - Nutricost Pomegranate Extract) - dose of 400 mg
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Nutricost Pomegranate Extract 15,000mg Equivalent from 1,000mg of 15:1 Extract Per Servings, 120 Capsules for 40 Servings Per Bottle - Vegan, GMO Free and Gluten Free;
다른 이름들:
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Alcohol Use Disorder (AUD) subjects
Adults ≥18; Must consume >20 standardized alcoholic beverages a week for the last 3 months for men, >14 standard alcoholic beverages a week for women; 3 capsules of the PDS (pomegranate dietary supplement - Nutricost Pomegranate Extract) - dose of 400 mg
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Nutricost Pomegranate Extract 15,000mg Equivalent from 1,000mg of 15:1 Extract Per Servings, 120 Capsules for 40 Servings Per Bottle - Vegan, GMO Free and Gluten Free;
다른 이름들:
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Alcoho-associated Cirrhosis (AC) patients
Adults ≥18; A history of alcohol consumption averaging at least 80 grams per day in men or 50 grams per day for women for at least 10 years; 3 capsules of the PDS (pomegranate dietary supplement - Nutricost Pomegranate Extract) - dose of 400 mg
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Nutricost Pomegranate Extract 15,000mg Equivalent from 1,000mg of 15:1 Extract Per Servings, 120 Capsules for 40 Servings Per Bottle - Vegan, GMO Free and Gluten Free;
다른 이름들:
|
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Early-Stage Alcohol-Associated Liver Disease
Adults ≥18; AUD qualifying criteria, plus ALT>40.
3 capsules of the PDS (pomegranate dietary supplement - Nutricost Pomegranate Extract) - dose of 400 mg
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Nutricost Pomegranate Extract 15,000mg Equivalent from 1,000mg of 15:1 Extract Per Servings, 120 Capsules for 40 Servings Per Bottle - Vegan, GMO Free and Gluten Free;
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To characterize the metabolite and cytokine profiles to inform future trials designed for enhancing cut barrier function
기간: 2036 yr.
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To evaluate the impact of pomegranate dietary supplements (PDS) on gut microbiome composition and epithelial barrier function in healthy, alcohol use disorder (AUD), early-stage ALD (eALD), and alcohol-associated liver cirrhosis (AC) subjects by characterizing the metabolite and cytokine profiles to inform future trials designed for enhancing cut barrier function in alcohol-associated liver disease (ALD).
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2036 yr.
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If inter-individual variation in gut microbiome is responsible for the production of beneficial metabolites
기간: 2036 yr.
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To determine if inter-individual variation in gut microbiome is responsible for the production of beneficial metabolites in healthy, AUD, eALD, and AC patients by correlating urolithin levels to inflammatory mediators in both healthy and diseased conditions.
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2036 yr.
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To determine if more correlative studies between produced metabolites, inflammatory mediators, and disease conditions could provide informed decisions during disease progression.
기간: 2036 yr.
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Develop identifiers for the pathology and treatment development of the study cohorts.
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2036 yr.
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To evaluate the omics of the subject and the microbiomes in their saliva, urine, and stool.
기간: 2036 yr.
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To evaluate the omics of the subject and the microbiomes in their saliva, urine, and stool.
This will help determine what response changes are genetic changes (both bacterial and human) in saliva; and omics, and genetic changes in stool and urine (both human and bacterial) could illustrate their role in profiling these potential modifiable risk factors for AUD/ALD.
The data could be correlated with the blood sample-derived cytokine, gut dysfunction, and candidate biomarkers of liver (K18s) and AUD severity (neurotransmitters, such as dopamine, GABA, serotonin, etc.)
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2036 yr.
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공동 작업자 및 조사자
수사관
- 연구 의자: Craig J McClain, MD, University of Louisville
- 연구 책임자: Vatsalya Vatsalya, MD, University of Louisville
- 수석 연구원: Venkatakrishna R Jala, PhD, University of Louisville
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 21.0999
- 2P50AA024337 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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