- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04659850
Impact of AGEs on Metabolism & Cognition (AGEs)
Do Dietary AGEs Have an Acute Effect on Metabolism and Cognition
연구 개요
상태
정황
상세 설명
This study will be a short-term, randomized, double-blind, cross-over trial. Volunteers will be younger (18-30 years) and older (55-75 years) men and women, normal and overweight (BMI>19 to 29.9). N=24 in each age group.
Medical screening for all study volunteers and neuropsychological screening will be carried out prior to study start. A small, pin prick, fasted blood sample will be taken to measure glucose and HbA1C levels to rule out type 2 diabetics. Anthropometric and body composition measurements will also be taken. Body weight and height will be measured using a scale and a stadiometer to the nearest 0.5 kg and 0.5 cm, respectively. Waist and hip circumferences will be measured and the waist-to-hip ratio calculated. Standard procedures will be followed for the anthropometric measurements and the average of three measurements taken. Neuropsychological screening may be repeated on another day if volunteers are borderline on their first visit as scores may vary by a couple of points depending on external events i.e. vounteers are having a bad day. Experienced staff will carry out abdominal fat measurements by manual determination of the area between the upper surface of the second lumbar vertebra, the lower surface of the fourth lumbar vertebra, and the lateral margins of the outer rib cage. If the Viscan is available we will use that to measure abdominal fat. Venous blood samples will be collected as appropriate for the hormones and metabolites to be tested and stored at -70 °C.
The day prior to the challenge volunteers will visit the Human Nutrition Unit (HNU, RINH). They will be given a low AGE breakfast and be supplied with a low AGE lunch and dinner for that day and instructed not to consume anything else. After an overnight fast volunteers will receive a one-off dose of either high AGE (11.4 mgs) or low AGE (2.4 mgs) whey protein delivered in a either a low or high fat milkshake (400ml) blended with flavours and a consistent quantity of sugar. All ingredients will be commercially available and of food grade. Apart from differences in fat and AGE the content of shakes will be closely balanced for sugar and other components. All participants will be asked to answer two questionnaires one to determine their habitual intake of dietary AGEs and one to determine their level of physical activity.
The different milkshakes will be tested with a minimum 7 day wash out period between tests. Volunteers will be randomised to each test group. After a 12 h overnight fast and a standardised intake the day prior to the tests, and no strenuous physical activity for 2 days previously, subjects will attend the HNU. Volunteers will be requested to provide a small urine sample for AGE analysis. An intravenous catheter will then be placed in an antecubital vein and flushed with saline between aspirations to keep the catheter clear. After a short resting period, a blood sample will be taken prior to the first memory test then a single milkshake will be consumed under supervision. Blood samples will be taken immediately before the milkshake ingestion (0 min) and after 30, 60, 90, 120, 150 and 180 and 240 min. Further computer based memory tests will be carried out at 30, 90 and 240 minutes. A urine sample will be requested at the end of the study before participants are offered lunch. Memory tests have been designed by Dr Ros Langston (University of Dundee) and Dr Kevin Allan, School of Psychology and will be carried out on lap tops specifically designated for this study. Blood and urine will be analysed for AGEs. Blood will also be analysed for glucose lipids and hormones. Dr Janice Drew will also analyse blood samples for gene expression of the SIRT-1/NAD+ complex indicative of the response of individuals to dietary challenge.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Scotland
-
Aberdeen, Scotland, 영국, AB252ZD
- University of Aberdeen Rowett Institute of Nutrition and Health
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Heathy
- Sedentary
- 18-30 or
- 55-75
Exclusion Criteria:
- diagnosed type 2 diabetes,
- CVD
- history of neurological abnormalities
- current psycho-active medication
- current anti-inflammatory medication
- Current glucose lowering medication
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Group 1
Group 1 participants in the young 18 - 30 age group
|
low fat, low AGE milkshake given after an overnight fast
low fat, high AGE milkshake given after an overnight fast
high fat, low AGE milkshake given after an overnight fast
high fat, high AGE milkshake given after an overnight fast
|
|
다른: Group 2
Group 2 participants in the older 55 - 75 age group
|
low fat, low AGE milkshake given after an overnight fast
low fat, high AGE milkshake given after an overnight fast
high fat, low AGE milkshake given after an overnight fast
high fat, high AGE milkshake given after an overnight fast
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Impact of Advanced Glycation End Products on Metabolism and Cognition
기간: Four weeks per participant
|
Habitual AGE intake, determined from dietary questionnaires, specifically designed for this purpose, taken at the start of the study, will be correlated with levels of circulating AGEs and outcomes such as inflammatory markers and expression of genes associated with susceptibility to metabolic disease and acute response to dietary challenge will be measured.
|
Four weeks per participant
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Fiona Campbell, PHD, UoA Rowett Institute of Nutrition and Health
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- 2017/RI/5
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
조건 없음에 대한 임상 시험
-
Heinrich-Heine University, Duesseldorf완전한
-
Charles River AnalyticsNational Institute on Drug Abuse (NIDA); Massachusetts General Hospital아직 모집하지 않음금연 + 12주간 표준 인지행동치료 | 가짜 NO VAPE + 12주 표준 CBT
-
Tianjin Medical University Cancer Institute and...모병
-
Tianjin Medical University Cancer Institute and...모병
-
Heinrich-Heine University, Duesseldorf완전한
low fat, low AGE milkshake에 대한 임상 시험
-
Pepperdine University모병
-
Anumana, Inc.Mayo Clinic종료됨
-
University of MichiganNational Institute on Drug Abuse (NIDA); Brown University; Pennington Biomedical Research... 그리고 다른 협력자들모병
-
Memorial Sloan Kettering Cancer CenterWeill Medical College of Cornell University종료됨