NCT04234373Active, not recruiting
Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot Trial
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
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 9 Jan 2020
- Start date
- 1 Jul 2020
- Primary completion date
- Dec 2026
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- Obesity
- NCT number
- NCT04234373
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Jul 2020 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Regular intake of medications, (oral contraceptives allowed)
- Intake of antibiotics within the last 3 months before inclusion
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
- Group B: PRE-DIABETIC or DIABETIC OBESE
- 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
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
Other illness
- Psychiatric illness
- 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
- Psychiatric illness
- 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
Other
- 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.)
- Alcohol abuse, (smoking allowed)
- Regular intake of pro- or prebiotics
- Pregnancy
- Pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates)
- Pre-existing diet (vegetarian, vegan, gluten-free etc.)
- Alcohol abuse, (smoking allowed)
- Regular intake of pro- or prebiotics
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Clara Research Ltd, St Claraspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.