NCT05821660

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

Metabolic Effects of a Five-day Remotely Delivered Hypocaloric and Ketogenic Program in Healthy Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Buchinger Wilhelmi Development & Holding GmbH · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy Nutrition
• Healthy Lifestyle

Interventions

Type	Name	Description
OTHER	Five-day hypocaloric and ketogenic programme	Dietary intervention

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-08-17
• Completion: 2023-08-17
• First posted: 2023-04-20
• Last updated: 2025-10-01

Locations

1 site across 1 country: Germany