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Clinical Trials/NCT05821660
NCT05821660CompletedNot Applicable

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

Buchinger Wilhelmi Development & Holding GmbH1 site in 1 country64 target enrollmentStarted: April 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
64
Locations
1
Primary Endpoint
Changes in body weight

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion 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

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

Arms & Interventions

Five-day hypocaloric and ketogenic programme

Experimental

The group will receive a five-day remotely delivered hypocaloric and ketogenic programme followed by a four-day food reintroduction period

Intervention: Five-day hypocaloric and ketogenic programme (Other)

Control

No Intervention

The group will maintain their habitual diet

Outcomes

Primary Outcomes

Changes in body weight

Time Frame: through study completion (11 subsequent days as well as one month afterwards)

in kg

Changes in systolic blood pressure

Time Frame: through study completion (11 subsequent days as well as one month afterwards)

in mmHg

Changes in diastolic blood pressure

Time Frame: through study completion (11 subsequent days as well as one month afterwards)

in mmHg

Secondary Outcomes

  • Changes in total cholesterol(At baseline, after 5 and 9 days as well as 1 month afterwards)
  • Changes in acetoacetic acid(through study completion (11 subsequent days as well as one month afterwards))
  • Changes in HDL-C(At baseline, after 5 and 9 days as well as 1 month afterwards)
  • Changes in ESR(At baseline, after 5 and 9 days as well as 1 month afterwards)
  • Changes in triglycerides(At baseline, after 5 and 9 days as well as 1 month afterwards)
  • Changes in HbA1c(At baseline, after 5 and 9 days as well as 1 month afterwards)
  • Changes in Insulin(At baseline, after 5 and 9 days as well as 1 month afterwards)
  • Changes in gut microbiome composition(At baseline, first stool after 9 days as well as 1 month afterwards)
  • Changes in LDL-C(At baseline, after 5 and 9 days as well as 1 month afterwards)
  • Changes in lipidperoxidation(At baseline, after 5 and 9 days as well as 1 month afterwards)
  • Changes in CRP(At baseline, after 5 and 9 days as well as 1 month afterwards)
  • Changes in IL-10(At baseline, after 5 and 9 days as well as 1 month afterwards)
  • Changes in well-being(through study completion (11 subsequent days as well as one month afterwards))
  • Changes in glucose(At baseline, after 5 and 9 days as well as 1 month afterwards)
  • Changes in total antioxidant capacity(At baseline, after 5 and 9 days as well as 1 month afterwards)
  • Changes in IL-6(At baseline, after 5 and 9 days as well as 1 month afterwards)
  • Changes in TNF-a(At baseline, after 5 and 9 days as well as 1 month afterwards)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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