Low-carb diet intervention for obese patients
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
NA · University Hospital, Basel, Switzerland · NCT04234373
This study is testing if a low-carb diet can help people who are obese and have glucose issues improve their health and manage their weight over six months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 1 site (Basel) |
| Trial ID | NCT04234373 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the effects of a 6-month low-carb dietary intervention on glycemic control, body composition, and gut-brain interaction in both obese and lean individuals, with a focus on those with glucose intolerance or diabetes. Participants will be divided into two groups: healthy lean controls and pre-diabetic or diabetic obese individuals. The study aims to assess how a low-carb diet influences metabolic health and weight management in these populations.
Who should consider this trial
Good fit: Ideal candidates include obese individuals with pre-diabetes or diabetes, as well as healthy lean controls for comparison.
Not a fit: Patients with pre-existing low-carb diets or specific dietary restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved glycemic control and weight management for obese patients with glucose intolerance or diabetes.
How similar studies have performed: Other studies have shown promising results with low-carb dietary interventions, suggesting potential effectiveness in managing obesity and glucose intolerance.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Basel
- St Clara Research Ltd, St Claraspital Basel — Basel, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Bettina Wölnerhanssen, MD — University Hospital, Basel, Switzerland
- Study coordinator: Bettina Wölnerhanssen, MD
- Email: bettina.woelnerhanssen@unibas.ch
- Phone: 0041616858585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glucose Intolerance, Obesity