Metabolic effects at two months from a fasting week
| ISRCTN | ISRCTN90206986 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90206986 |
| Protocol serial number | BASEC2019-00415 |
| Sponsor | Fondazione Hospice Ticino |
| Funder | Interlude Bien-être Sarl |
- 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
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
Scientific
Fondazione Hospice Ticino
viale dei Faggi 8
Lugano
6900
Switzerland
| Phone | +41 (0)79 174 53 27 |
|---|---|
| mauro.frigeri@hospice.ch |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study lasting 2 years |
| Secondary study design | Cohort study |
| 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 |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/06/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Informed consent 2. Participating in a fasting week at the Centre Interlude Bien-être 3. Age ≥ 20 years, ≤ 70 years |
| Key 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 |
| Date of first enrolment | 30/04/2019 |
| Date of final enrolment | 31/05/2021 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
1873
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The 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
- Protocol file
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.
