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Fastreset Study: Metabolic Effects of a Five-day Remotely Delivered Hypocaloric and Ketogenic Program

B

Buchinger Wilhelmi Development

Status

Enrolling

Conditions

Healthy Lifestyle
Healthy Nutrition

Treatments

Other: Five-day hypocaloric and ketogenic programme

Study type

Interventional

Funder types

Other

Identifiers

NCT05821660
F-2023-014

Details and patient eligibility

About

The aim of this study is to assess changes in body and metabolism caused by this new five-day hypocaloric and ketogenic programme

Full description

Therapeutic effects of fasting are increasingly documented. Recent studies on a cohort of subjects doing a long-term fasting lasting from 4 days to several weeks demonstrated beneficial effects on health and well-being. In recent studies on the therapeutic efficacy of the Buchinger Wilhelmi fasting program, long-term fasting significantly improved risk factors for a variety of chronic diseases including hypertension even in medicated subjects, liver steatosis, inflammation, oxidative stress and lipoprotein distribution.

There is an increasing demand for dietary interventions which can be delivered at home. This has been amplified by the Coronavirus-19 disease (COVID-19) pandemic during which many countries kept their population in lockdown at home in isolation. The COVID-19 pandemic has also influenced the lifestyle of individuals, with an increased consumption of unhealthy food and a sedentary behaviour resulting in mental (anxiety, depression, and others) and physical (weight gain, rise in blood pressure) health issues. In order to adapt to this new context, the Buchinger Wilhelmi Clinics have created a hypocaloric, ketogenic program with interval fasting.

The five-day programme is designed to be easily integrated into everyday life and can be applied several times a year. The programme is based on ready-to-eat soups made with locally sourced organic ingredients. The ingredients represent a total daily intake of around 600 kcal per day - with a high share of fats and a limited quantity of carbohydrates and proteins. Minerals and micronutrients used at the Buchinger Wilhelmi Clinics are also supplied. Although the comprehensive medical care and assistance offered at the clinics cannot be replicated, medical professionals are available to support the customers remotely.

The investigators hypothesise that the metabolic changes caused by this new five-day programme can be similar to a short-term fast. In order to test this hypothesis, the investigators will perform a two-arm randomized controlled trial in which a group of participants will perform the five-day Fastingbox programme and a group of participants will receive an eucaloric diet as a control group.

Enrollment

64 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Exclusion Criteria:

  • Not able to sign the informed consent
  • diagnosticated with cachexia, anorexia, nervosa, advanced kidney, liver or cerebrovascular insufficiency.
  • Intake of antibiotics up to 2 months prior the study
  • Medicated high blood pressure
  • Diagnosed hyperuricemia
  • Diagnosed diabetes mellitus type I and II
  • Diagnosed kidney stone
  • Active malignant diseases
  • Known substance addiction
  • Pregnancy or breastfeeding
  • Participation in another study

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

Five-day hypocaloric and ketogenic programme
Experimental group
Description:
The group will receive a five-day remotely delivered hypocaloric and ketogenic programme followed by a four-day food reintroduction period
Treatment:
Other: Five-day hypocaloric and ketogenic programme
Control
No Intervention group
Description:
The group will maintain their habitual diet

Trial contacts and locations

1

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Central trial contact

Buchinger Wilhelmi Clinic; Françoise Wilhelmi de Toledo, Dr.

Data sourced from clinicaltrials.gov

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