Skip to content

Promoting immune health by intermittent fasting: a pilot study

Promoting immune health by intermittent fasting: a pilot study - TIGER

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51683
Enrollment
24
Registered
2022-12-05
Start date
2023-01-01
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metabolic syndrome

Interventions

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 fo

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026