Promoting immune health by intermittent fasting: a pilot study

Conditions: metabolic syndrome
10018424

Registration Number: NL-OMON51683

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 24

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to determine the direct effects of long-term<br /><br>intermittent fasting on immune cell populations in the blood, combined with<br /><br>analyses of systemic metabolic fitness and inflammatory activation of<br /><br>leukocytes.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are to determine:<br /><br>- Shifts in immune cell populations and inflammatory activation of leukocytes.<br /><br>- The effect of IF on the transcriptional and epigenetic repertoire of<br /><br>monocytes.<br /><br>- The fitness of monocyte responses by analysing their response to an<br /><br>inflammatory metabolic challenge (i.e., mixed meal challenge).<br /><br>- The effect of IF on metabolic parameters such as body weight, resting energy<br /><br>expenditure, insulin sensitivity, glucose tolerance and postprandial bile acid<br /><br>and FGF-19 responses.<br /><br>- The effect of IF on gut microbiota.</p><br>