To study the direct effects of long-term intermittent fasting on immune cell populations in the blood, combined with analyses of systemic metabolic fitness and inflammatory activation of leukocytes.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to determine the direct effects of long-term
intermittent fasting on immune cell populations in the blood, combined with
analyses of systemic metabolic fitness and inflammatory activation of
leukocytes.
Secondary outcome
Secondary objectives are to determine:
- Shifts in immune cell populations and inflammatory activation of leukocytes.
- The effect of IF on the transcriptional and epigenetic repertoire of
monocytes.
- The fitness of monocyte responses by analysing their response to an
inflammatory metabolic challenge (i.e., mixed meal challenge).
- The effect of IF on metabolic parameters such as body weight, resting energy
expenditure, insulin sensitivity, glucose tolerance and postprandial bile acid
and FGF-19 responses.
- The effect of IF on gut microbiota.
Background summary
Atherosclerosis related myocardial infarction and stroke are the main causes of
cardiovascular disease (CVD) in Western society. Lifestyle changes such as
changes in diet, smoking, and exercise clearly are very effective for CVD
prevention. As atherosclerotic disease is driven by both lipid-related
mechanisms (i.e., hyperlipidemia) and inflammatory processes, we envision that
novel approaches to modulate the inflammatory status of patients may provide
strong new tools to further diminish CVD burden.
In this study, we aim to investigate the direct effects of long-term
intermittent fasting on the molecular characteristics of monocytes and their
related health benefits. We want to assess the postprandial inflammation and
the potential protective role of IF on postprandial monocyte activation and its
related health benefits. This pilot study may give us a better understanding of
the molecular mechanisms behind IF which could result in further
personalization of life-style guidance and identification of novel
anti-inflammatory processes that control immune responses and inflammation.
Study objective
To study the direct effects of long-term intermittent fasting on immune cell
populations in the blood, combined with analyses of systemic metabolic fitness
and inflammatory activation of leukocytes.
Study design
This study is designed as a single-centre, proof of concept, randomized
cross-over study.
Intervention
Subject will participate in both arms of this cross-over study in which they
oblige to both a daily time-restricted eating (TRE) protocol and a control
protocol for each two weeks, separated by a four-week wash-out period.
Study burden and risks
There will be 5 study visits for which subjects have to come in fastened: 1 for
screening, 2 at the start of the intervention, and 2 for the high fat meal
challenges (HFMC) in the AMC. Additionally, halfway the intervention, a
telephone consult with a dietician will take place to check for questions
regarding nutritional intake. The screening visit will take 30 minutes,
including physical examination and a blood withdrawal (12 mL). At the start of
each intervention, subjects will come to the AMC for a visit of 30 minutes. A
blood sample will be taken (48 mL). On the day of the HFMC, morning stool
samples will be collected and blood will be taken from subjects (48mL) followed
by frequent blood sampling after the consumption of a standardized liquid meal
from an intravenous (IV) cannula (total blood withdrawal 146,5mL). Each HFMC
will take approximately 6 hours. The total amount of blood drawn during this
study will be 497 mL. Indirect calorimetry requires that the subjects breathe
into a mask for 20 minutes while lying in a supine position. Lifestyle
intervention studies might prevent cardiovascular diseases by lowering body
weight and/or increasing metabolic flexibility. Therefore, MetS subjects might
benefit from this study. By including healthy subjects, more insight into
metabolic flexibility in subjects who are in good health can be gathered and
might provide us a starting point for other (cardio) vascular diseases.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
the at-risk group:
• Body mass index (BMI) 30 to 43 kg/m2)
• HOMA-IR index of >= 2.5 (measured as fasting insulin (pmol/L) x fasting
glucose (mmol/L)) / 135)
• At least 3 out of 5 NCEP metabolic syndrome criteria
Healthy group
• Body mass index (BMI) 18 to 25 kg/m2,
• Waist circumference between 79 cm and 94 cm,
• HOMA-IR index <= 2.0
Exclusion criteria
- Excessive weight loss of >10% in the last months;
- Use of any medication
- Pregnant, trying to get pregnant or breast feeding at inclusion;
- Irregular menstrual cycle;
- Hormonal replacement therapy.
- Cholecystectomy;
- Untreated GI disease/abnormal bowel habits;
- A history of cardiovascular event (MI or pacemaker implantation)
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 |
|---|---|
| CCMO | NL81296.018.22 |