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

NCT05821660 | Completed

• 1 other identifier: F-2023-014
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Nutrition; Healthy Lifestyle

Keywords

hypocaloric and ketogenic diet; intestinal microbiota; inflammatory status

Outcome Measures

Primary Outcomes (3)

• Changes in body weight

  in kg

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

• Changes in systolic blood pressure

  in mmHg

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

• Changes in diastolic blood pressure

  in mmHg

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

Secondary Outcomes (17)

• Changes in acetoacetic acid

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

• Changes in total cholesterol

  At baseline, after 5 and 9 days as well as 1 month afterwards

• Changes in HDL-C

  At baseline, after 5 and 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 triglycerides

  At baseline, after 5 and 9 days as well as 1 month afterwards

Other Outcomes (54)

• Changes in body mass index

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

• Changes in abdominal circumference

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

• Changes in resting heart frequency

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

Study Arms (2)

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

Other: Five-day hypocaloric and ketogenic programme

Control

NO INTERVENTION

The group will maintain their habitual diet

Interventions

Five-day hypocaloric and ketogenic programme OTHER

Dietary intervention

Also known as: Buchinger Wilhelmi Fastingbox

Five-day hypocaloric and ketogenic programme

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Buchinger Wilhelmi Development & Holding GmbH: lead
• Buchinger Wilhelmi Clinic: collaborator
• King's College London: collaborator
• MVZ Labor Ravensburg GbR: collaborator
• Synlab Málaga: collaborator

Study Sites (1)

Buchinger Wilhelmi Clinic

Überlingen, Baden-Wurttemberg, 88662, Germany

Location

Study Officials

• Françoise Wilhelmi de Toledo, Dr.

  Buchinger Wilhelmi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, two-arm interventional study

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 20, 2023
• Study Start: April 1, 2023
• Primary Completion: August 17, 2023
• Study Completion: August 17, 2023
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

DE (1)