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Alternating Energy Intake and Blood Fat Content After a Meal

25 augustus 2022 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Verwacht)

23

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Nederland
    • Limburg
      • Maastricht, Limburg, Nederland, 6229 ER
        • Werving
        • Maastricht University Medical Center
        • Contact:
        • Hoofdonderzoeker:
          • Ronald P. Mensink, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Alternating energy intake schedule
To alternate between caloric overconsumption and caloric underconsumption from day-to-day
Ander: 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.
Actieve vergelijker: Regular energy intake schedule
To consume the usual energy intake on a daily basis
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Triacylglycerol area under the curve (AUC)
Tijdsspanne: 4 hours
The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal
4 hours

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fasting glucose metabolism
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 24 hours
MAGE as parameter for the assessment of glycemic variability.
24 hours
Continuous overall net glycemic action (CONGA)
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
High-Sensitivity C-Reactive Protein (hs-CRP) levels
Tijdsspanne: Baseline, week 2, and twice in week 4
Fasting hs-CRP as inflammatory marker
Baseline, week 2, and twice in week 4
Blood pressure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Maastricht University Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 juli 2021

Primaire voltooiing (Verwacht)

1 december 2022

Studie voltooiing (Verwacht)

1 december 2022

Studieregistratiedata

Eerst ingediend

20 april 2021

Eerst ingediend dat voldeed aan de QC-criteria

18 mei 2021

Eerst geplaatst (Werkelijk)

20 mei 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 augustus 2022

Laatste update ingediend die voldeed aan QC-criteria

25 augustus 2022

Laatst geverifieerd

1 augustus 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • METC 20-089

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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