Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot Trial

April 28, 2026 updated by: University Hospital, Basel, Switzerland

Understanding Gut-brain Interactions and the Effect of a Low-carb Dietary Intervention in Obese Patients With and Without Glucose Intolerance or Diabetes: a Pilot Trial

Effects of a 6 months low-carb dietary intervention on glycemic control, body composition and gut-brain interaction in obese and lean patients with and without glucose intolerance or diabetes

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4002
        • St Clara Research Ltd, St Claraspital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Group A: HEALTHY LEAN CONTROLS

  • Healthy normal weight subjects with a body-mass index of 19.0-24.9kg/m2, HbA1C <5.7% and fasting glucose <5.6 mmol/l
  • Normal eating habits
  • Stable body weight for at least three months
  • Informed Consent as documented by signature

Group B: PRE-DIABETIC or DIABETIC OBESE

  • Pre-diabetic/Diabetic obese with a HbA1C >5.7% and/or fasting glucose >5.6 mmol/l) and body-mass index > 30kg/m2, otherwise healthy
  • Normal eating habits
  • Stable body weight for at least three months
  • Informed Consent as documented by signature

Exclusion Criteria:

Group A: HEALTHY LEAN CONTROLS

  • Pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates)
  • Pre-existing diet (vegetarian, vegan, gluten-free etc.)
  • Psychiatric illness
  • Alcohol abuse, (smoking allowed)
  • Regular intake of medications, (oral contraceptives allowed)
  • Intake of antibiotics within the last 3 months before inclusion
  • Regular intake of pro- or prebiotics
  • Chronic diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract (e.g. bariatric surgery)
  • Clinically relevant acute or chronic inflammatory disease
  • Pregnancy
  • Participation in another study with investigational drug within the 30 days preceding and during the present study.

Group B: PRE-DIABETIC or DIABETIC OBESE

  • Pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates)
  • Pre-existing diet (vegetarian, vegan, gluten-free etc.)
  • Psychiatric illness
  • Alcohol abuse, (smoking allowed)
  • Regular intake of medications (except: oral contraceptives, metformin, SGLT-2, statins, and antihypertensive, which are allowed)
  • Intake of antibiotics within the last 3 months before inclusion
  • Regular intake of pro- or prebiotics
  • Chronic diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract (e.g. bariatric surgery)
  • Clinically relevant acute or chronic inflammatory disease
  • Pregnancy
  • Participation in another study with investigational drug within the 30 days preceding and during the present study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Carb dietary Intervention
Other: Low Carb diet
Low Carb diet (max. 130g carbohydrates/d) for 6 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Effect of a low-carb dietary intervention on glycemic control as defined by blood glucose level at 2h after an oral glucose tolerance test.
Time Frame: Change from baseline to 6 months
Change from baseline to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect of a low-carb dietary intervention on body composition as measured with dual-energy x-ray absorptiometry
Time Frame: Change from baseline to 6 months
Change from baseline to 6 months
Effect of a low-carb dietary intervention on metabolomics as measured in plasma, urine and stool samples
Time Frame: Change from baseline to 6 months
Metabolomic analysis of the bacterial metabolites present in the urine by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry
Change from baseline to 6 months
Effect of a low-carb dietary intervention on gut microbiota composition as measured in stool samples
Time Frame: Change from baseline to 6 months
Human gut microbiota composition measured with metagenomic shotgun sequencing
Change from baseline to 6 months
Effect of a low-carb dietary Intervention on brain network activity as measured with functional MRI
Time Frame: Change from baseline to 6 months
Change from baseline to 6 months
Effect of a low-carb dietary intervention on liver fat fraction as measured with MRI
Time Frame: Change from baseline to 6 months
Change from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bettina Wölnerhanssen, MD, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LCP Obese

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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