Alternating Energy Intake and Blood Fat Content After a Meal
25 augusti 2022 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
23
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Maite M. Schroor, MSc.
- Telefonnummer: +31433884258
- E-post: maite.schroor@maastrichtuniversity.nl
Studera Kontakt Backup
- Namn: Ronald P. Mensink, PhD
- Telefonnummer: +31433881308
- E-post: r.mensink@maastrichtuniversity.nl
Studieorter
-
-
Limburg
-
Maastricht, Limburg, Nederländerna, 6229 ER
- Rekrytering
- Maastricht University Medical Center
-
Kontakt:
- Maite M. Schroor, MSc.
- Telefonnummer: +31433884258
- E-post: maite.schroor@maastrichtuniversity.nl
-
Huvudutredare:
- Ronald P. Mensink, PhD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Alternating energy intake schedule
To alternate between caloric overconsumption and caloric underconsumption from day-to-day
|
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
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Triacylglycerol area under the curve (AUC)
Tidsram: 4 hours
|
The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal
|
4 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fasting glucose metabolism
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 24 hours
|
MAGE as parameter for the assessment of glycemic variability.
|
24 hours
|
|
Continuous overall net glycemic action (CONGA)
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
High-Sensitivity C-Reactive Protein (hs-CRP) levels
Tidsram: Baseline, week 2, and twice in week 4
|
Fasting hs-CRP as inflammatory marker
|
Baseline, week 2, and twice in week 4
|
|
Blood pressure
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
14 juli 2021
Primärt slutförande (Förväntat)
1 december 2022
Avslutad studie (Förväntat)
1 december 2022
Studieregistreringsdatum
Först inskickad
20 april 2021
Först inskickad som uppfyllde QC-kriterierna
18 maj 2021
Första postat (Faktisk)
20 maj 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 augusti 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 augusti 2022
Senast verifierad
1 augusti 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- METC 20-089
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .