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Alternating Energy Intake and Blood Fat Content After a Meal

25. august 2022 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

23

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Holland
    • Limburg
      • Maastricht, Limburg, Holland, 6229 ER
        • Rekruttering
        • Maastricht University Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Ronald P. Mensink, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Alternating energy intake schedule
To alternate between caloric overconsumption and caloric underconsumption from day-to-day
Andet: Alternating Energy Intake
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.
Aktiv komparator: Regular energy intake schedule
To consume the usual energy intake on a daily basis
Andet: Regular Energy Intake
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Triacylglycerol area under the curve (AUC)
Tidsramme: 4 hours
The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal
4 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fasting glucose metabolism
Tidsramme: Baseline, week 2, and twice in week 4
Fasting glucose metabolism (includes e.g. glucose and insulin concentrations)
Baseline, week 2, and twice in week 4
Fasting lipid metabolism
Tidsramme: Baseline, week 2, and twice in week 4
Fasting serum lipid and lipoprotein profile
Baseline, week 2, and twice in week 4
Marker for postprandial lipid metabolism
Tidsramme: 4 hour period after consumption of a standardised mixed meal
Marker for lipid metabolism includes triacylglycerol and will be measured after consumption of a standardised mixed meal
4 hour period after consumption of a standardised mixed meal
Markers for postprandial glucose metabolism
Tidsramme: 4 hour period after consumption of a standardised mixed meal
Markers for glucose metabolism include insulin and glucose and will be measured after consumption of a standardised mixed meal
4 hour period after consumption of a standardised mixed meal
24-hour glucose levels
Tidsramme: 24 hours
The total area under the curve (tAUC) for 24-hour glucose as measured with a continuous glucose sensor
24 hours
Day-time glucose levels
Tidsramme: From 07:00 to 22:00 (15 hours)
The tAUC for day-time glucose (07:00 - 22:00 h) as measured with a continuous glucose sensor
From 07:00 to 22:00 (15 hours)
Night-time glucose levels
Tidsramme: From 22:01 to 06:59 (8 hours and 58 min)
The tAUC for night-time glucose (22:01 - 06:59 h) as measured with a continuous glucose sensor
From 22:01 to 06:59 (8 hours and 58 min)
Glucose levels after main meal consumption
Tidsramme: 2 hours
The tAUC for glucose during 2 hours after main meal consumption (breakfast, lunch and dinner) as measured with a continuous glucose sensor.
2 hours
The mean amplitude of glycemic excursions (MAGE)
Tidsramme: 24 hours
MAGE as parameter for the assessment of glycemic variability.
24 hours
Continuous overall net glycemic action (CONGA)
Tidsramme: 1 hour, 2 hours, and 4 hours
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).
1 hour, 2 hours, and 4 hours

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
High-Sensitivity C-Reactive Protein (hs-CRP) levels
Tidsramme: Baseline, week 2, and twice in week 4
Fasting hs-CRP as inflammatory marker
Baseline, week 2, and twice in week 4
Blood pressure
Tidsramme: Baseline, week 2, week 3, and twice in week 4
Office systolic and diastolic blood pressure
Baseline, week 2, week 3, and twice in week 4
Body weight
Tidsramme: Baseline, week 2, week 3, and twice in week 4
Body weight in kilograms
Baseline, week 2, week 3, and twice in week 4
Height
Tidsramme: Baseline, week 2, week 3, and twice in week 4
Height in centimeters
Baseline, week 2, week 3, and twice in week 4
Body Mass Index
Tidsramme: Baseline, week 2, week 3, and twice in week 4
Body weight and height will be combined to report BMI in kg/m^2
Baseline, week 2, week 3, and twice in week 4
Waist circumference
Tidsramme: Baseline, week 2, week 3, and twice in week 4
Waist circumference in centimeters
Baseline, week 2, week 3, and twice in week 4
Hip circumference
Tidsramme: Baseline, week 2, week 3, and twice in week 4
Hip circumference in centimeters
Baseline, week 2, week 3, and twice in week 4
Waist to hip ratio
Tidsramme: Baseline, week 2, week 3, and twice in week 4
Waist and hip circumference will be used to report the waist to hip ratio
Baseline, week 2, week 3, and twice in week 4

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Maastricht University Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. juli 2021

Primær færdiggørelse (Forventet)

1. december 2022

Studieafslutning (Forventet)

1. december 2022

Datoer for studieregistrering

Først indsendt

20. april 2021

Først indsendt, der opfyldte QC-kriterier

18. maj 2021

Først opslået (Faktiske)

20. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. august 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. august 2022

Sidst verificeret

1. august 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • METC 20-089

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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