Clinical trial NCT05821660: Fastreset Study: Metabolic Effects of a Five-day Remotely Delivered Hypocaloric and Ketogenic Program
Official title: Metabolic Effects of a Five-day Remotely Delivered Hypocaloric and Ketogenic Program in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Nutrition
Healthy Lifestyle
Keywords: hypocaloric and ketogenic diet
intestinal microbiota
inflammatory status
Lead sponsor: Buchinger Wilhelmi Development & Holding GmbH
Sponsor class: OTHER
Collaborators: name: Buchinger Wilhelmi Clinic
name: King's College London
name: MVZ Labor Ravensburg GbR
name: Synlab Málaga
First posted: 2023-04-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, two-arm interventional study
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Changes in body weight
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in systolic blood pressure
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in diastolic blood pressure
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
Secondary outcomes:
measure: Changes in acetoacetic acid
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in total cholesterol
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in HDL-C
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in LDL-C
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in triglycerides
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in glucose
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in HbA1c
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in Insulin
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in total antioxidant capacity
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in lipidperoxidation
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in well-being
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in ESR
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in CRP
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in IL-6
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in IL-10
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in TNF-a
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in gut microbiome composition
timeFrame: At baseline, first stool after 9 days as well as 1 month afterwards
Other outcomes:
measure: Changes in body mass index
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in abdominal circumference
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in resting heart frequency
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in leucocytes
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in erythrocytes
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in haemoglobin
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in haematocrit
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in MCV
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in MCH
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in MCHC
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in thrombocytes
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in INR
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in PTT
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in kidney parameters
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in uric acid
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in urea
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in creatinine
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in GOT
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in GPT
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in GGT
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in AP
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in sodium
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in potassium
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in calcium
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in magnesium
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in continous glucose monitoring
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in physical activity level
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in sleep quality
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in processed food consumption
timeFrame: At baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in physical well-being
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in emotional well-being
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in energy level
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in cravings
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in feeling bloated
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in feeling cold
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in tiredness
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in muscle weakness
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in back pain
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in headache
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in hunger
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in anxiety
timeFrame: through study completion (11 subsequent days as well as one month afterwards9
measure: Changes in digestive problems
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in optimism
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in relaxation
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in clear thinking
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in confidence
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in happiness
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Changes in physical activity
timeFrame: through study completion (11 subsequent days as well as one month afterwards)
measure: Ethnicity
timeFrame: baseline
measure: Smoking
timeFrame: baseline
measure: Alcohol consumption
timeFrame: baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in stress level
timeFrame: baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in energy level
timeFrame: baseline, after 5 and 9 days as well as 1 month afterwards
measure: Changes in pain level
timeFrame: baseline, after 5 and 9 days as well as 1 month afterwards
Locations:
city: Überlingen
country: Germany
facility: Buchinger Wilhelmi Clinic
state: Baden-Württemberg
Study officials:
affiliation: Buchinger Wilhelmi
name: Françoise Wilhelmi de Toledo, Dr.
role: PRINCIPAL_INVESTIGATOR
References: