Alternating Energy Intake and Blood Fat Content After a Meal
25. august 2022 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
23
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Maite M. Schroor, MSc.
- Telefonnummer: +31433884258
- E-post: maite.schroor@maastrichtuniversity.nl
Studer Kontakt Backup
- Navn: Ronald P. Mensink, PhD
- Telefonnummer: +31433881308
- E-post: r.mensink@maastrichtuniversity.nl
Studiesteder
-
-
Limburg
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Maastricht, Limburg, Nederland, 6229 ER
- Rekruttering
- Maastricht University Medical Center
-
Ta kontakt med:
- Maite M. Schroor, MSc.
- Telefonnummer: +31433884258
- E-post: maite.schroor@maastrichtuniversity.nl
-
Hovedetterforsker:
- Ronald P. Mensink, PhD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fasting glucose metabolism
Tidsramme: Baseline, week 2, and twice in week 4
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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
|
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Marker for postprandial lipid metabolism
Tidsramme: 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
|
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).
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1 hour, 2 hours, and 4 hours
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. juli 2021
Primær fullføring (Forventet)
1. desember 2022
Studiet fullført (Forventet)
1. desember 2022
Datoer for studieregistrering
Først innsendt
20. april 2021
Først innsendt som oppfylte QC-kriteriene
18. mai 2021
Først lagt ut (Faktiske)
20. mai 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. august 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. august 2022
Sist bekreftet
1. august 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- METC 20-089
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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