- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05384106
AN OPEN-LABEL, ACUTE CLINICAL TRIAL TO ASSESS THE LEVEL OF KETONE PRODUCTION FOLLOWING CONSUMPTION OF AVELA™ (R)-1,3-BUTANEDIOL IN AN ADULT POPULATION
연구 개요
상세 설명
Primary:
To evaluate the level of production of BHB following the consumption of 3 servings of Avela™, with consumption of each serving separated by 30 minutes and each serving providing 11.5 g of (R)-1,3-butanediol [total intake of 34.5 g of (R)-1,3-butanediol].
BHB levels will be measured using capillary whole blood from the fingertips using at home Keto-Mojo monitoring system (β-Ketone, as beta-hydroxybutyrate, in fingertip capillary whole blood).
Measurement Range: 0.1 - 8.0 mmol/L Measurement time (min): 0, 30, 60, 90, 120, 180, 240, 300
Secondary:
To evaluate the acute effects of 3 servings of Avela™, with consumption of each serving separated by 30 minutes and each serving providing 11.5 g of (R)-1,3-butanediol [i.e., total intake of 34.5 g (R)-1,3-butanediol] on: GI tolerance.
All subjects will complete the mVAS GI symptoms tool at baseline (0 minutes), and at 30, 60, 90, 120, 180, 240, and 300 minutes.
A validated tool to measure GI tolerability of (R)-1,3-butanediol will be utilized. The mVAS GI symptoms tool is a self-administered questionnaire, which is modeled after the validated "gold standard" measurement tool predominantly used to test clinical gastroenterology scenarios (Bengtsson et al., 2013).
Sleepiness/alertness The SSS (Shahid et al., 2012) is a subjective tool to assess how alert a subject is feeling at specific moments in time. The scale requires respondents to select a rating of 1 to 7, where a "1" indicates the subject is "feeling active, vital, alert, or wide awake" and the highest score of "7" indicates the subject is "no longer fighting sleep, sleep onset soon; having dream-like thoughts" (Hoddes et al., 1973). The scale is validated, correlating r = 0.68 with performance on the Wilkinson tests. All subjects will complete the SSS at baseline (0 minutes) and at 30, 60, 90, 120, 180, 240, and 300 minutes.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: James Lowder, MD
- 전화번호: 619-387-7120
- 이메일: research@impactsciencealliance.org
연구 연락처 백업
- 이름: Vassili Kotlov
- 전화번호: 619-387-7120
- 이메일: research@impactsciencealliance.org
연구 장소
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California
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San Diego, California, 미국, 92106
- Moniker Commons
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연락하다:
- Vassili Kotlov
- 이메일: research@impactsciencealliance.org
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Males and females, 18 to 65 years of age
- BMI 18 to <35.0 kg/m2, inclusive
- Weight ≥ 110 lbs
- Subject is judged to be in good health on the basis of medical history
- Subject is willing to fast for 12 hours prior to study start
- Subject is willing to avoid alcohol and intense physical activity the day prior to and on the day of testing
- Subject is capable of giving informed consent and complying with all study procedures/requirements.
Exclusion Criteria:
- Previous GI disorders (e.g., inflammatory bowel disease, irritable bowel syndrome, history of surgery for weight loss, or gastroparesis)
- Gastroenteritis in the 2 weeks preceding the study
- Diabetes
- Weight <110 lbs
- History of alcohol or drug abuse
- Previous diagnosis of neurological disorders, depression, or mental illness with psychosis
- Unexplained alarm features (i.e., unintentional weight loss >10% body weight in the last 3 months, fevers, or blood in stools)
- Use of an antibiotic or any medication impacting gut transit during the 2 weeks before the study
- Constipation or diarrhea (defined as, on average, less than 3 stools per week or more than 3 stools per day, respectively)
- Allergy to tree nuts
- Women who are pregnant or breastfeeding
- Persons with medical conditions affecting the pancreas, liver, thyroid, or gall bladder.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Avela™ (R)-1,3-Butanediol
3 servings of Avela™, with consumption of each serving separated by 30 minutes and each serving providing 11.5 g of (R)-1,3-butanediol [total intake of 34.5 g of (R)-1,3-butanediol].
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Avela™ (R)-1,3-butanediol is intended to induce ketosis in the general adult population.
Avela™ (R)-1,3-butanediol is GRAS for use in beverages, bars, and gels
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
To evaluate the level of production of BHB measure of blood ketones levels (i.e., blood BHB levels)
기간: 0, 30, 60, 90, 120, 180, 240, and 300 minutes
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β-Ketone, as beta-hydroxybutyrate, in fingertip capillary whole blood, Measurement Range: 0.1 - 8.0 mmol/L
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0, 30, 60, 90, 120, 180, 240, and 300 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
To assess GI symptomology
기간: 0, 30, 60, 90, 120, 180, 240, and 300 minutes
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Modified visual analogue scale (mVAS) GI symptoms tool
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0, 30, 60, 90, 120, 180, 240, and 300 minutes
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To assess Sleepiness/alertness
기간: 0, 30, 60, 90, 120, 180, 240, and 300 minutes
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Stanford Sleepiness Scale (SSS)
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0, 30, 60, 90, 120, 180, 240, and 300 minutes
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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
기타 연구 ID 번호
- 1129
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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