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Different Types of Fruits on Metabolic Function and Cognitive Performance (WBB2)

The Effect of Different Types of Fruits on Metabolic Function and Cognitive Performance

Primary objective is to assess the effect of the intake of different types of fruits on memory and attention.

Secondary objective is to assess effect of intake of different types of fruits on metabolic markers, including glucose, insulin, total cholesterol and triglyceride and the pharmacokinetic profile of the anthocyanins.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

The trial is designed as a randomized 2-arm, placebo-controlled, within-subjects crossover utilizing a multiple sampling, repeated measures paradigm to investigate the effects of consumption of different types of fruits on cognitive performance and metabolic responses. This trial will test 2 treatment conditions in forty men and women who will be enrolled into the study.

Each subject will be asked to come for one screening visit, a pre-study visit, and two dinner pick-ups the day before each of the two test visits and 2 test visits. Participation in this study will last approximately four weeks.

The initial screening visit will provide the subject with the informed consent document and determine eligibility through anthropometric measurements, vital signs, fasting blood glucose test , vein assessment, color test and completion of a survey relate to general eating, health, and exercise habits. In addition, subjects will take brief tests of attention and memory to ensure capability and willingness to perform tests during subsequent research visits. Eligible subjects will be trained and instructed to record all food and beverages consumed for a 3-day period (one weekend day and two weekdays) on food record diaries. At the pre-study visit, subjects will be instructed to follow a strictly limited polyphenolic diet for 7 days prior to the study and throughout their participation time, while maintaining their usual diet pattern and physical activity. A dinner meal will be provided the day before the study visit.

At each test visit, subjects will arrive at the clinic after fasting 8 to 12 hours and in a well-hydrated state. After confirming compliance with protocol, anthropometric measurements and vital signs will be taken along with a finger prick for fasting blood glucose and a catheter placement .

Fasting baseline blood sample from a catheter will be collected after which baseline cognitive performance measures will be assessed. After completing baseline measures, subjects will receive a standard breakfast meal along with a beverage containing different fruits according to the randomization sequence. Additional blood samples will be taken at 30, 60, 120, 180, 240, 300, 360, and 480 minutes after the start of the breakfast meal. Additional cognitive tests will be performed at the 120, 240, 360, and 480 minute time points. A standardized lunch will be provided between the 360 and 480 minute time points.

Subject will come to the clinic for 2 test day visits; all procedures will be the same except for the treatment (the test or control treatment).

연구 유형

중재적

등록 (실제)

40

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Illinois
      • Chicago, Illinois, 미국, 60616
        • Clinical Nutrition Research Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

40년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

  • • Subject is male or female aged between 40 and 65 years of age

    • Subject has BMI between 18.5 and 34.9 kg/m2, (inclusive) at screening visit
    • Fasting blood sugar less than 126 mg/dL
    • Average Blood pressure less than 160/100 mmHg
    • Subject is willing to maintain a stable body weight and to follow his/her regular diet and physical activity patterns throughout the study period.
    • Subject is willing to refrain from vigorous physical activity and consumption of alcoholic and/or caffeinated beverages 24 h prior to each test day
    • Subject does not smoke or has abstained from smoking for at least 2 years
    • No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
    • Not taking any medications or dietary supplements that would interfere with outcomes of the study.

Exclusion Criteria:

  • • Subject currently smokes or has smoked within the past 2 years

    • Subject works overnight i.e. the night shift
    • Subjects who have a significant sleep disorder, a traumatic brain injury, have a learning disability or attention deficit disorder or any psychiatric or neurological disturbances
    • Subject is color blind, has impaired cognitive performance on the flanker test (score <60 at screening) or has a vein access score <7
    • Men and women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compounds
    • Men and women known to have/diagnosed with diabetes mellitus
    • Men and women with a fasting blood glucose concentration ≥126 mg/dL
    • Average blood pressure > 160/100 mmHg during screening visit
    • Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries
    • Men and women with cancer other than non-melanoma skin cancer in previous 2 years
    • Men and women who are taking medication or dietary supplements that may interfere with the study procedures or the endpoints of the study (e.g. antioxidants, anti-inflammatory medications, antidepressant medications, oral and injectable hypoglycemic medications, GI medications, antibiotics, diuretics, adrenergic blockers etc.) Subjects may choose to go off dietary supplements (requires 30 days washout)
    • Men and women taking antibiotics within 5 days of study start
    • Men and women who have donated blood/plasma within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months
    • Substance (alcohol or drug) abuse within the last 2 years
    • Excessive coffee and tea consumption (> 4 cups/day)
    • Unstable body weight fluctuations of >4.5kg (9.9lbs) in the past 4 weeks
    • Women who are known to be pregnant or who are intending to become pregnant over the course of the study and women who are lactating.
    • Men and women whom investigator is uncertain about subject's capability or willingness to comply with protocol requirements
    • Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months.
    • Men and women who do excessive exercise regularly or are athlete

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Treatment 1 Beverage
Treatment 1
Treatment 1 Beverage
위약 비교기: Treatment 2 Beverage
Treatment 2
Treatment 2 Beverage

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Changes in memory function using the Montreal Cognitive Assessment after intake of different types of fruits
기간: 8 hours Postprandial Study
Sum all sub-scores of the Montreal Cognitive Assessment
8 hours Postprandial Study

2차 결과 측정

결과 측정
측정값 설명
기간
Changes in plasma glucose concentrations after intake of different types of fruits
기간: 8 hours Postprandial Study
plasma glucose concentrations after intake of different types of fruits
8 hours Postprandial Study
Changes in plasma insulin concentrations after intake of different types of fruits
기간: 8 hours Postprandial Study
insulin concentrations after intake of different types of fruits
8 hours Postprandial Study
Changes in plasma Triglycerides Concentrations after intake of different types of fruits
기간: 8 hours Postprandial Study
Plasma Triglycerides Concentrations after intake of different types of fruits
8 hours Postprandial Study
Changes in plasma Total Cholesterol Concentrations after intake of different types of fruits
기간: 8 hours Postprandial Study
plasma Total Cholesterol Concentrations after intake of different types of fruits
8 hours Postprandial Study

기타 결과 측정

결과 측정
측정값 설명
기간
Changes in polyphenol anthocyanin concentrations after intake of different types of fruits
기간: 8 hours Postprandial Study
polyphenol anthocyanin concentrations after intake of different types of fruits
8 hours Postprandial Study
Changes in LDL oxidation after intake of different types of fruits
기간: 8 hours Postprandial Study
OxLDL after intake of different types of fruits
8 hours Postprandial Study
Changes in IL-6 after intake of different types of fruits
기간: 8 hours Postprandial Study
IL-6 after intake of different types of fruits
8 hours Postprandial Study
Changes in IL-1beta after intake of different types of fruits
기간: 8 hours Postprandial Study
IL-1beta after intake of different types of fruits
8 hours Postprandial Study
Changes in IL-10 after intake of different types of fruits
기간: 8 hours Postprandial Study
IL-10 after intake of different types of fruits
8 hours Postprandial Study
Changes in MCP-1 after intake of different types of fruits
기간: 8 hours Postprandial Study
MCP-1 after intake of different types of fruits
8 hours Postprandial Study

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 3월 2일

기본 완료 (실제)

2019년 10월 30일

연구 완료 (실제)

2020년 7월 30일

연구 등록 날짜

최초 제출

2016년 3월 31일

QC 기준을 충족하는 최초 제출

2016년 4월 12일

처음 게시됨 (추정)

2016년 4월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 7월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 7월 26일

마지막으로 확인됨

2021년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • IRB2015-105

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .

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