Metabolic effects at two months from a fasting week

ISRCTN ISRCTN90206986
DOI https://doi.org/10.1186/ISRCTN90206986
Secondary identifying numbers BASEC2019-00415
Submission date
12/03/2019
Registration date
18/03/2019
Last edited
16/08/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Mauro Frigeri
Scientific

Fondazione Hospice Ticino
viale dei Faggi 8
Lugano
6900
Switzerland

Phone +41 (0)79 174 53 27
Email mauro.frigeri@hospice.ch

Study information

Study designObservational cohort study lasting 2 years
Primary study designObservational
Secondary study designCohort study
Study setting(s)Other
Study typePrevention
Scientific titleObservational 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
Study objectivesThe voluntary realisation of a week-long fast has objective metabolic effects that persist at two months from the beginning of the fast.
Ethics approval(s)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
Health condition(s) or problem(s) studiedClients of the Centre Interlude Bien-être, where a week of fasting is done voluntarily
InterventionStudy 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 typeBehavioural
Primary outcome measurePlasma 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 measures1. 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 study start date30/04/2018
Completion date30/06/2021

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants100 (20 included in the group selected for the blood test)
Total final enrolment40
Key inclusion criteria1. Informed consent
2. Participating in a fasting week at the Centre Interlude Bien-être
3. Age ≥ 20 years, ≤ 70 years
Key exclusion criteria1. 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
Date of first enrolment30/04/2019
Date of final enrolment31/05/2021

Locations

Countries of recruitment

  • Switzerland

Study participating centre

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

Sponsor information

Fondazione Hospice Ticino
Other

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

Phone +41 (0)791745327
Email mauro.frigeri@hospice.ch
Website http://www.digiunoesalute.ch

Funders

Funder type

Industry

Interlude Bien-être Sarl

No information available

Results and Publications

Intention to publish date01/01/2023
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 17/01/2021 11/05/2021 Yes No
Protocol file version 1.2 07/04/2019 16/08/2022 No No

Additional files

36461 Protocol v1.2 07Apr2019.pdf

Editorial Notes

16/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
11/05/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
3. The study has ended.
17/07/2019: The ethics approval was added.