Glucose IntoleranceNCT04234373
Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot Trial
A study testing Low Carb diet in people with Glucose Intolerance and Obesity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance, Obesity
- What is being tested?
- Low Carb diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2020to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Glucose Intolerance, Obesity
- Being tested
- Low Carb diet
- Medical subject headings
- Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Carb dietOther
Low Carb diet (max. 130g carbohydrates/d) for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Low Carb dietary Intervention | Experimental | Not described Receives: Other: Low Carb diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of a low-carb dietary intervention on glycemic control as defined by blood glucose level at 2h after an oral glucose tolerance test.
Measured: Change from baseline to 6 months
Secondary outcomes (5)
Effect of a low-carb dietary intervention on body composition as measured with dual-energy x-ray absorptiometry
Measured: Change from baseline to 6 months
Effect of a low-carb dietary intervention on metabolomics as measured in plasma, urine and stool samples
Metabolomic analysis of the bacterial metabolites present in the urine by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry
Measured: Change from baseline to 6 months
Effect of a low-carb dietary intervention on gut microbiota composition as measured in stool samples
Human gut microbiota composition measured with metagenomic shotgun sequencing
Measured: Change from baseline to 6 months
Effect of a low-carb dietary Intervention on brain network activity as measured with functional MRI
Measured: Change from baseline to 6 months
Effect of a low-carb dietary intervention on liver fat fraction as measured with MRI
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Jul 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bettina Wölnerhanssen, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234373
- Sponsor's protocol ID
- LCP Obese
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2020
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04234373
- Acronym / sponsor ID
- LCP Obese
- Conditions
- Glucose Intolerance, Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Carb dietary Intervention | Experimental | Other: Low Carb diet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (24 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Carb dietLow Carb diet (max. 130g carbohydrates/d) for 6 months | Other | Low Carb dietary Intervention |
Primary outcome
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
5 secondary outcomes
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
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
Effect of a low-carb dietary intervention on gut microbiota composition as measured in stool samples
Time frame: 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
Effect of a low-carb dietary intervention on liver fat fraction as measured with MRI
Time frame: Change from baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bettina Wölnerhanssen, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Carb diet in people with Glucose Intolerance and Obesity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.