Alternating Energy Intake and Blood Fat Content After a Meal
2022년 8월 25일 업데이트: Maastricht University Medical Center
The Effect of Alternating Energy Intake Compared to Regular Energy Intake on the Fat Content in the Blood After a Meal in Abdominally Obese Adults
Increasing evidence suggests that meal timing affects metabolic health.
For example, intermittent fasting (IF) may have positive effects on plasma glucose and lipid levels, insulin sensitivity, and blood pressure.
However, IF protocols often result in significant weight loss.
Therefore, it is not clear to what extent these beneficial metabolic effects are due to IF or to weight loss.
Although the effect of IF independent of weight loss has been studied, daily energy intake in those studies did not differ between the days.
Therefore, the investigators aim to examine the effect of alternating energy intake - i.e. standardised day-to-day fluctuations in energy intake - on metabolic health independent of weight loss.
연구 개요
연구 유형
중재적
등록 (예상)
23
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Maite M. Schroor, MSc.
- 전화번호: +31433884258
- 이메일: maite.schroor@maastrichtuniversity.nl
연구 연락처 백업
- 이름: Ronald P. Mensink, PhD
- 전화번호: +31433881308
- 이메일: r.mensink@maastrichtuniversity.nl
연구 장소
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Limburg
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Maastricht, Limburg, 네덜란드, 6229 ER
- 모병
- Maastricht University Medical Center
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연락하다:
- Maite M. Schroor, MSc.
- 전화번호: +31433884258
- 이메일: maite.schroor@maastrichtuniversity.nl
-
수석 연구원:
- Ronald P. Mensink, PhD
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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, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Apparently healthy men and women as judged by study physician
- Abdominally obese males (waist circumference ≥ 102 cm) and females (waist circumference ≥ 88 cm)
- Aged between 18 - 75 years
- Stable bodyweight (weight gain or loss ≤ 3 kg in the past three months)
- Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- No difficult venipuncture as evidenced during the screening visit
- Women should be pre- or postmenopausal
- Sedentary (light exercise < 1 h per week) or moderately active (moderate exercise 1-2 h per week)
- Having a general practitioner
- Agreeing that the participant and general practitioner will be informed about medically relevant personal test results by a physician
- Willing to comply to study protocol during study
- Informed consent signed
Exclusion Criteria:
- Fasting plasma glucose ≥ 7 mmol/l
- Fasting serum triacylglycerol ≥ 4.5 mmol/l
- Fasting serum total cholesterol ≥ 8 mmol/l
- Blood pressure ≥ 160/100 mm Hg
- Current smoker, or smoking cessation < 12 months
- Drug abuse
- Alcohol abuse (≥ 21 alcohol consumptions per week)
- Use of medication known to affect blood pressure, serum lipid metabolism, or glucose metabolism
- Having a medical condition or history which might impact study measurements, to be judged by the study physician (e.g. myocardial infarction, angina, thrombosis, stroke, cancer, familiar hypercholesterolemia, liver or bowel disease or diabetes)
- Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Use of an investigational product within another biomedical intervention trial within the previous 1-month
- Women who are perimenopausal, have an irregular menstrual cycle, or are pregnant
- Use of over-the-counter and prescribed medication, which may interfere with study measurements (to be judged by the principal investigator), e.g. weight loss medication
- Reported dietary habits: medically prescribed diets or slimming diets
- Reported participation in night shift work 2 weeks prior to screening and/or during the study. Night work is defined as working between midnight and 6.00 AM
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Alternating energy intake schedule
To alternate between caloric overconsumption and caloric underconsumption from day-to-day
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To alternate between caloric overconsumption (130% of usual total energy needs) and caloric underconsumption (70% of usual total energy needs) on a daily basis for 6 days/week followed by one ad libitum day for 4 weeks.
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활성 비교기: Regular energy intake schedule
To consume the usual energy intake on a daily basis
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To consume the usual energy intake (100% of total energy needs) on a daily basis for 6 days/week, also followed by one ad libitum day for 4 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Triacylglycerol area under the curve (AUC)
기간: 4 hours
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The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal
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4 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fasting glucose metabolism
기간: Baseline, week 2, and twice in week 4
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Fasting glucose metabolism (includes e.g.
glucose and insulin concentrations)
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Baseline, week 2, and twice in week 4
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Fasting lipid metabolism
기간: Baseline, week 2, and twice in week 4
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Fasting serum lipid and lipoprotein profile
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Baseline, week 2, and twice in week 4
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Marker for postprandial lipid metabolism
기간: 4 hour period after consumption of a standardised mixed meal
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Marker for lipid metabolism includes triacylglycerol and will be measured after consumption of a standardised mixed meal
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4 hour period after consumption of a standardised mixed meal
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Markers for postprandial glucose metabolism
기간: 4 hour period after consumption of a standardised mixed meal
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Markers for glucose metabolism include insulin and glucose and will be measured after consumption of a standardised mixed meal
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4 hour period after consumption of a standardised mixed meal
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24-hour glucose levels
기간: 24 hours
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The total area under the curve (tAUC) for 24-hour glucose as measured with a continuous glucose sensor
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24 hours
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Day-time glucose levels
기간: From 07:00 to 22:00 (15 hours)
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The tAUC for day-time glucose (07:00 - 22:00 h) as measured with a continuous glucose sensor
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From 07:00 to 22:00 (15 hours)
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Night-time glucose levels
기간: From 22:01 to 06:59 (8 hours and 58 min)
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The tAUC for night-time glucose (22:01 - 06:59 h) as measured with a continuous glucose sensor
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From 22:01 to 06:59 (8 hours and 58 min)
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Glucose levels after main meal consumption
기간: 2 hours
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The tAUC for glucose during 2 hours after main meal consumption (breakfast, lunch and dinner) as measured with a continuous glucose sensor.
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2 hours
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The mean amplitude of glycemic excursions (MAGE)
기간: 24 hours
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MAGE as parameter for the assessment of glycemic variability.
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24 hours
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Continuous overall net glycemic action (CONGA)
기간: 1 hour, 2 hours, and 4 hours
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CONGA to assess intraday glucose variability within predetermined time windows -> 1-hour interval (CONGA-1), 2-hour interval (CONGA-2), and 4-hour interval (CONGA-4).
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1 hour, 2 hours, and 4 hours
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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High-Sensitivity C-Reactive Protein (hs-CRP) levels
기간: Baseline, week 2, and twice in week 4
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Fasting hs-CRP as inflammatory marker
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Baseline, week 2, and twice in week 4
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Blood pressure
기간: Baseline, week 2, week 3, and twice in week 4
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Office systolic and diastolic blood pressure
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Baseline, week 2, week 3, and twice in week 4
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Body weight
기간: Baseline, week 2, week 3, and twice in week 4
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Body weight in kilograms
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Baseline, week 2, week 3, and twice in week 4
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Height
기간: Baseline, week 2, week 3, and twice in week 4
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Height in centimeters
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Baseline, week 2, week 3, and twice in week 4
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Body Mass Index
기간: Baseline, week 2, week 3, and twice in week 4
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Body weight and height will be combined to report BMI in kg/m^2
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Baseline, week 2, week 3, and twice in week 4
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Waist circumference
기간: Baseline, week 2, week 3, and twice in week 4
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Waist circumference in centimeters
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Baseline, week 2, week 3, and twice in week 4
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Hip circumference
기간: Baseline, week 2, week 3, and twice in week 4
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Hip circumference in centimeters
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Baseline, week 2, week 3, and twice in week 4
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Waist to hip ratio
기간: Baseline, week 2, week 3, and twice in week 4
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Waist and hip circumference will be used to report the waist to hip ratio
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Baseline, week 2, week 3, and twice in week 4
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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연구 주요 날짜
연구 시작 (실제)
2021년 7월 14일
기본 완료 (예상)
2022년 12월 1일
연구 완료 (예상)
2022년 12월 1일
연구 등록 날짜
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2021년 4월 20일
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처음 게시됨 (실제)
2021년 5월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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마지막으로 확인됨
2022년 8월 1일
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