Clinical trial
Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot Trial
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04234373
Active, not recruitingNot applicableInterventional
What this study is about
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
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 55 Years
SexAll
Healthy volunteersAccepted
ConditionGlucose Intolerance, Obesity
Full registry 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.
Treatments and study arms
Low Carb diet
Other
Low Carb diet (max. 130g carbohydrates/d) for 6 months
Primary outcomes
Effect of a low-carb dietary intervention on glycemic control as defined by blood glucose level at 2h after an oral glucose tolerance test.Change from baseline to 6 months
Study locations
1 locations were listed when this page was built. The first 40 are shown.
St Clara Research Ltd, St Claraspital Basel🇨🇭 Basel, Switzerland