Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06745362

Weight Reduction With the Low-Insulin-Method - Self Monitoring of Breath Acetone

The goal of this clinical trial is to learn if lifestyle intervention with information about ketosis state supports weight reduction in overweight adults.

Researchers will compare an App-based lifestyle intervention with self-monitoring of breath acetone vs. lifestyle intervention alone.

Participants will:

Get a lifestyle intervention via the LIM-App for 12 months. Report body weight.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Overweight and Obese Volunteers Acid-Base Imbalance Acidosis Body Weight Body Weight Changes Ketosis Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Background: Overweight and obesity are an increasing problem. Therefore, the Low-Insulin-Method was developed to support overweight and obese people in weight loss.

Method: In a randomized controlled clinical trial, the effect of the lifestyle intervention program 'Low-Insulin-Method', delivered by the Low-Insulin-App including low-carb diet, physical activity, self monitoring of weight, and self-monitoring of breath acetone (SMBA) is examined compared to a control group without information about ketosis level. Weight change will be compared after 3 and 12 months.

Objective: The aim is to develop a training and counseling program for overweight or obese individuals with diabetes risk or type 2 diabetes, which can be used both for primary and for tertiary prevention of overweight-related diseases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index > 25kg/m2

Exclusion criteria

-

Treatment and study plan

self-monitoring of breath acetone

Other

Participants perform self-monitoring of braeth acetone in order to get information about their ketosis state.

lifestyle-intervention via LIM-App

Other

Participants are offered a lifestyle intervention via LIM-App.

Primary outcomes

  1. body weight

    Time frame: 3 months

    body weight in kg

Secondary outcomes

  1. body weight

    Time frame: 12 months

    body weight in kg

Study contacts

Contact information is provided by the study sponsor or research team.

Stephan Martin

CONTACT

[email protected]

049-2115660360 ext. 70

Sponsors and collaborators

Lead sponsor

West German Center of Diabetes and Health

Other

Registry information

Acronym: WeR-LIM-SMBA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2024
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.