The Effect of Macronutrients on Fibroblast Growth Factor 21 (FGF21) Secretion
2022년 3월 30일 업데이트: University of Copenhagen
The aim of this randomized cross-over study is to investigate how consumption of protein and fat affects the FGF21 response triggered by sucrose. The hypothesis is that the consumption of protein, but not fat, will attenuate the FGF21 response triggered by sucrose.
Exploratory, and in order to investigate mechanisms behind the potential attenuation in the sucrose-induced FGF21 response after protein consumption, glucose, insulin, glucagon, triglycerides, amino acids, glicentin and cholecystokinin (CCK) will be assessed before and after consumption of sucrose, sucrose+protein and sucrose+fat. Furthermore, the association between the FGF21 response after consumption of sucrose, sucrose + protein and sucrose + fat and subjective rating of appetite for sweet will also be investigated.
연구 개요
연구 유형
중재적
등록 (실제)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Frederiksberg, 덴마크, 1958
- Department of Nutrition, Exercise and sports, University of Copenhagen
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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
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Informed consent
- Caucasian
- Healthy men and women
- Age between 18-50 years
- Body mass index (BMI) between 20-27 kg/m2
Exclusion Criteria:
- Chronic diseases or significant health problems that are disruptive for participation in the study (as judged by the principal investigator/clinical responsible)
- Use, currently or within the previous 3 months, of medication that has the potential of affecting any of the blood parameters assessed in the study (as judged by the principal investigator/clinical responsible)
- Blood donation within the last 3 months or during the study period
- Smoking, smoking cessation within the past 3 months, or nicotine use (electronic cigarettes, gum, etc.)
- Currently dieting or having lost/gained a significant amount of weight (±3 kg) in the previous 3 months
- Women who are pregnant, breast-feeding or have the intention of becoming pregnant during the study period
- Food allergies or food intolerance relevant for the study
- Substance abuse (within the last 12 months)
- Alcohol intake above the recommendations from the Danish Health and Medicines Authority
- Simultaneous participation in other clinical studies that can interfere with the current study
- Inability, physically or mentally, to comply with the procedures required by the study protocol
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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Sucrose
The participants will be served a test drink with 75g sucrose dissolved in water
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The participants consume A) water with 75 g sucrose
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실험적: Sucrose + protein
The participants will be served a test drink with 75g sucrose dissolved in water and ~ 100 kcal protein (whey protein)
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The participants consume B) water with 75 g sucrose + approx.
100 kcal protein
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실험적: Sucrose + fat
The participants will be served a test drink with 75g sucrose dissolved in water and ~ 100 kcal fat (cream)
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The participants C) water with 75 g sucrose + approx.
100 kcal fat
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in FGF21 concentration after consumption of sucrose vs. sucrose+protein
기간: Difference in plasma concentration of FGF21 between two test days
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Difference (pg/ml) in plasma FGF21 concentration after consumption of sucrose vs. sucrose+protein.
Concentration of FGF21 is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma concentration of FGF21 between two test days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in FGF21 concentration after consumption of sucrose vs. sucrose+fat
기간: Difference in plasma concentration of FGF21 between two test days
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Difference (pg/ml) in plasma FGF21 concentration after consumption of sucrose vs. sucrose+fat.
FGF21 is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma concentration of FGF21 between two test days
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Difference in glucose concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
기간: Difference in plasma concentration of glucose between the three test days
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Difference (mmol/l) in plasma glucose concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Glucose is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma concentration of glucose between the three test days
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Difference in insulin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
기간: Difference in serum concentration of insulin between the three test days
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Difference (pmol/l) in serum insulin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Insulin is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in serum concentration of insulin between the three test days
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Difference in glucagon concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
기간: Difference in plasma concentration of glucagon between the three test days
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Difference (pg/ml) in plasma glucagon concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Glucagon is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma concentration of glucagon between the three test days
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Difference in triglyceride concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
기간: Difference in serum concentration of triglycerides between the three test days
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Difference (mmol/l) in serum triglyceride concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Triglyceride is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in serum concentration of triglycerides between the three test days
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Difference in amino acid concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
기간: Difference in serum concentration of amino acids between the three test days
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Difference in serum amino acid concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Amino acids are measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in serum concentration of amino acids between the three test days
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Difference in glicentin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
기간: Difference in plasma glicentin between the three test days
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Difference (pmol/l) in plasma glicentin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Glicentin is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma glicentin between the three test days
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Difference in CCK concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
기간: Difference in plasma CCK between the three test days
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Difference (pmol/l) in plasma CCK concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
CCK is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma CCK between the three test days
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Difference in appetite for sweet after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
기간: Difference in appetite for sweet between the three test days
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Difference in appetite for sweet is measured using visual analog scales (VAS).
The VAS consists of a 100 mm horizontal unbroken line with words anchored at each end describing the extremes.
The participants respond to the question asked by placing a vertical mark through the horizontal line corresponding to their perceived feeling at that particular time.
Appetite for sweet is assessed at time 0 and 30, 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in appetite for sweet between the three test days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Matthew P Gillum, Novo Nordisk Foundation Center for Basic Metabolic Research, Health and Medical Sciences, University of Copenhagen
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)
2021년 9월 28일
기본 완료 (실제)
2022년 2월 23일
연구 완료 (실제)
2022년 2월 23일
연구 등록 날짜
최초 제출
2021년 9월 9일
QC 기준을 충족하는 최초 제출
2021년 9월 27일
처음 게시됨 (실제)
2021년 9월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 3월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 3월 30일
마지막으로 확인됨
2021년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- The FGF21-macro study
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
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