Condition category
Not Applicable
Date applied
12/03/2019
Date assigned
18/03/2019
Last edited
17/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Fasting is an emerging practice as a preventive method. The media coverage of this nutritional method is increasing in Switzerland. The CIBE (Interlude Bien-être Center [www.interludebienetre.ch]) offers one week fast paid stays. The preventive properties of fasting are supported by preclinical data and scattered clinical trials. Preclinical research on fasting and caloric restriction suggests a beneficial effect on health. These benefits translate into increased longevity and decreased risk of heart disease and cancer. The aim of this study is to find out whether there is a persistence of metabolic effects after 2 months in non-diabetic people who are fasting for a week at CIBE.

Who can participate?
Clients at the Interlude Bien-être Center (Val d’Illiez, Valais, Switzerland) who voluntarily fast for a week

What does the study involve?
During the study, physical measurements (body composition, abdominal circumference, blood pressure, body temperature, body mass index, heart rate) and, for a selected group (more at risk of metabolic syndrome according to the measurements of abdominal circumference, body mass index, blood pressure), laboratory tests (lipid profile, blood glucose, protein C reactive, IGF-1) are carried out. These values are recorded at the beginning and end of the fast, and two months after the start of the fast. Forms on eating habits and physical activity are completed before fasting and two months later.

What are the possible benefits and risks of participating?
The participants thanks to these tests benefit from a screening (e. g. blood pressure, lipid profile, variation of body composition). Furthermore, they should return to the Center Interlude Bien-être two months after fasting. The greatest risk is related to blood sampling which causes an injury to the elbow crook, which can bleed, cause an ecchymosis (discoloration), a hematoma (swelling) and, rarely, become complicated by infection and thrombosis.

Where is the study run from?
Centre Interlude Bien-Être (Switzerland)

When is the study starting and how long is it expected to run for?
April 2018 to June 2021

Who is funding the study?
The study is partially funded by the company Interlude Bien-être Sarl. Research and statistical analysis costs are borne by researchers (Mauro Frigeri, MD; Valeria Galetti, PhD; Marica Brnic Bontognali, PhD)

Who is the main contact?
Mauro Frigeri
mauro.frigeri@hospice.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mauro Frigeri

ORCID ID

Contact details

Fondazione Hospice Ticino
viale dei Faggi 8
Lugano
6900
Switzerland
+41 (0)79 174 53 27
mauro.frigeri@hospice.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BASEC2019-00415

Study information

Scientific title

Observational study on metabolic effects for clients who fast for one week at the Centre Interlude Bien-être, two months after the onset of fasting: body composition and plasma LDL cholesterol concentration

Acronym

Study hypothesis

The voluntary realisation of a week-long fast has objective metabolic effects that persist at two months from the beginning of the fast.

Ethics approval

Approved 24/04/2019, Commission cantonale d’éthique de la recherche sur l’être humain du canton de Vaud (avenue de Chailly 23, 1012 Lausanne, Switzerland; +41 21 316 18 30; secretariat.cer@vd.ch), ref: 2019-00415

Study design

Observational cohort study lasting 2 years

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Clients of the Centre Interlude Bien-être, where a week of fasting is done voluntarily

Intervention

Study participants are recruited from clients at the Interlude Bien-être Center (Val d’Illiez, Valais, Switzerland) who voluntarily fast for a week. Body composition, blood pressure (TA), body mass index (BMI), abdominal circumference (CA), temperature, heart rate and, in a group selected (BMI ≥ 30kg/m2, or TA ≥ 130/85mmHg or antihypertensive drug, or CA ≥ 80cm in women and ≥ 94cm in men) for blood sampling, blood glucose, lipid profile, insulin-like growth factor 1 (IGF-1), C-reactive protein (CRP) are compared between before fasting, after fasting and at two months from the beginning of fasting. Forms describing diet and physical activity are completed before fasting and two months after the start of fasting.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Plasma LDL cholesterol (laboratory analysis in mmol/l) measured at the onset of fasting and two months after the beginning of the fasting week, in the group selected for blood sampling

Secondary outcome measures

1. Total cholesterol (mmol/l), HDL cholesterol (mmol/l), triglycerides (mmol/l), blood glucose (mmol/l), CRP (mg/l) and IGF-1 (ng/ml), in the group selected for blood sampling (laboratory analysis), and variation in BMI (kg/m2), CA (cm), TA (mmHg), heart rate (/min), temperature (°C), measured at the beginning of the fast and 2 months after
2. The same measures (and LDL cholesterol) at the beginning and at the end of the fast
3. Fat-free mass measured by bioelectrical impedance analysis at 50 kHz with Nutrigard MS performed at the beginning, end and 2 months after the beginning of the fast

Overall trial start date

30/04/2018

Overall trial end date

30/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Informed consent
2. Participating in a fasting week at the Centre Interlude Bien-être
3. Age ≥ 20 years, ≤ 70 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

100 (20 included in the group selected for the blood test)

Participant exclusion criteria

1. Diabetes mellitus or taking glucose-lowering medication
2. BMI <18kg/m2
3. Known eating disorders (orthorexia, anorexia, bulimia)
4. Known metabolic pathologies that contraindicate fasting (e.g. deficiencies gluconeogenesis)
5. Pregnant women or during the lactation period

Recruitment start date

30/04/2019

Recruitment end date

31/05/2021

Locations

Countries of recruitment

Switzerland

Trial participating centre

Centre Interlude Bien-Être
Val-d'Illiez (Valais)
1873
Switzerland

Sponsor information

Organisation

Fondazione Hospice Ticino

Sponsor details

Groupe pour l'étude du jeûne (Mauro Frigeri
MD; Valeria Galetti
PhD; Marica Brnic Bontognali
PhD)
c/o Mauro Frigeri
viale dei Faggi 8
Lugano
6900
Switzerland
+41 (0)791745327
mauro.frigeri@hospice.ch

Sponsor type

Other

Website

http://www.digiunoesalute.ch

Funders

Funder type

Industry

Funder name

Interlude Bien-être Sarl

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/01/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/07/2019: The ethics approval was added.