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Metabolic Flexibility and Ketone Production During Energy Deficit

NCT07429058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-24

No results posted yet for this study

Summary

This randomized, interventional study examines the effects of short-term carbohydrate restriction, with and without caloric restriction, on indices of metabolic flexibility in healthy adults. Participants are randomly assigned to either a low-carbohydrate diet or a standard diet under energy balance, followed by the same diet under controlled caloric restriction. Primary outcomes include measures of carbon dioxide production, breath ketones and interstitial glucose. Secondary outcomes include blood and urinary ketones, body weight, body composition, and selected metabolic biomarkers.

Conditions

  • Dietary Carbohydrate Restriction, Energy Deficit

Interventions

OTHER

Low-Carbohydrate Diet

Participants receive a low-carbohydrate diet. All meals are provided and individually tailored based on estimated energy requirements. Carbohydrate intake is restricted to 75-125 g per day, with the remaining energy intake derived from fat and protein. The intervention is administered for 14 days.

OTHER

Standard Diet With Caloric Restriction

Participants receive a standard mixed diet. All meals are provided and individually tailored based on estimated energy requirements. The macronutrient distribution consists of approximately 50-55% carbohydrates, 25-35% fat, and 15% protein. The intervention is administered for 14 days.

Sponsors & Collaborators

  • Metaflow Ltd.

    collaborator UNKNOWN

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Karsten Köhler, Prof. Dr. · Professorship for Exercise, Nutrition and Health, Technical University of Munich

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-24
Primary Completion
2024-03-11
Completion
2024-04-26

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07429058 on ClinicalTrials.gov