The primary objective is to compare the effect of a 4-week alternating energy intake schedule to a 4-week regular energy intake schedule on the postprandial triacylglycerol (TAG) response to a mixed meal in adults with abdominal obesity. Secondary…
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is the difference in the area under the curve
(AUC) for TAG after a mixed meal challenge between the end of the 4-
week alternating and regular eating schedules. Secondary endpoints include
fasting lipid metabolism, fasting glucose metabolism, and postprandial
glycaemic responses.
Secondary outcome
Glucose metabolism:
- Fasting glucose, insulin, and C-peptide concentrations
From the CGM:
- The total area under the curve (tAUC) for 24-hour glucose, day-time glucose
(07:00 am * 22:00 pm), and night-time glucose (22:01 pm * 06:59 am).
- The tAUC for glucose during 2 hours after main meal consumption (breakfast,
lunch and dinner)
- The mean amplitude of glycemic excursions (MAGE) as parameter for the
assessment of glycemic variability.
- Continuous overall net glycemic action (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).
From the mixed meal (postprandial responses):
- TAG iAUC, maximal increase TAG, time to peak TAG
- NEFA AUC, NEFA dAUC, maximal decrease NEFA, time to nadir NEFA
- Glucose AUC, glucose iAUC, maximal increase glucose, time to peak glucose
- Insulin AUC, insulin iAUC, maximal increase insulin, time to peak insulin
- C-peptide AUC, C-peptide iAUC, maximal increase C-peptide, time to peak
C-peptide
Lipid metabolism:
- Fasting serum lipid and lipoprotein profile (TC, HDL-C, LDL-C, TAG)
- Fasting serum non-cholesterol sterols as markers for intestinal cholesterol
absorption (campesterol, sitosterol, cholestanol) and endogenous cholesterol
synthesis (lathosterol and desmosterol)
Background summary
Increasing evidence suggests that meal timing affects metabolic health. For
example, intermittent fasting (IF) may have positive effects on plasma glucose
levels, insulin sensitivity, plasma lipids, 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, we here propose to examine the effect of alternating energy intake *
i.e. standardized day-to-day fluctuations in energy intake * on metabolic
health independent of weight loss.
Study objective
The primary objective is to compare the effect of a 4-week alternating energy
intake schedule to a 4-week regular energy intake schedule on the postprandial
triacylglycerol (TAG) response to a mixed meal in adults with abdominal
obesity. Secondary objectives include fasting lipid metabolism, fasting glucose
metabolism, and postprandial glycaemic responses.
Study design
A randomized, single-blind, cross-over study will be carried out. The total
study duration will be at least 12 weeks, including an intervention and
comparison period of 4 weeks each, separated by a washout period of at least 4
weeks.
Intervention
Participants will be randomly allocated to start with a 4-week alternating
energy intake schedule or a 4-week regular energy intake schedule. Participants
in the alternating energy intake schedule will be asked to alternate between
caloric overconsumption (i.e. 130% of their total energy needs) and caloric
underconsumption (i.e. 70% of their total energy needs) for 6 days/week
followed by one ad libitum day/week. Participants in the regular energy intake
schedule will be asked to consume their habitual energy intake to maintain a
stable bodyweight (i.e. 100% of total energy needs) for 6 days/week followed by
one ad libitum day/week.
Study burden and risks
Before the start of the study, subjects will be screened to determine
eligibility during a 30 min visit. During this visit, bodyweight, height, hip
and waist circumference, and blood pressure will be measured, and a fasting
blood sample (5.5 mL) will be drawn by means of venapunction. Thereafter,
participants will be asked to fill in a medical, general, and physical activity
questionnaire.
During the study, participants will come to the University for an assessment of
outcome measures on day 1, day 14, day 21, and the last three days of the
4-week eating schedule. On all visits, except for day 21, a fasting blood
sample will be drawn (with a total of 70 mL spread over the 6 visits), and
bodyweight, height, hip and waist circumference, and blood pressure will be
measured. On day 21, anthropometrics will be performed and a continuous glucose
monitor (CGM) will be attached to the upper-arm of the participant to measure
interstitial glucose concentrations for 9 or 10 days. The CGM will be removed
at the end of the 4-week eating schedule (day 30 or 31).
At the end of both eating schedules (i.e. on day 30 or 31) participants will
come to the university for a mixed meal test. For this test, an intravenous
cannula will be inserted in the antecubital vein, and blood samples will be
collected 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes (81 mL) after meal
consumption.
All participants will register food intake twice a week in a diary, and report
any signs of illness, medication used, and deviations from the protocol. On
rare occasions, blood sampling may cause bruises or hematoma. Total time
investment for the participants will be approximately 17 hours and 45
minutes.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
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
* Women should be pre- or postmenopausal
* No difficult venipuncture as evidenced during the screening visit
* 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Het onderzoek is in Clinicaltrials.gov geregistreerd onder NCT04894526. |
| CCMO | NL74940.068.20 |