Glucose Intolerance, Obesity
Conditions
Brief 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
Interventions
OTHERLow Carb diet
Low Carb diet (max. 130g carbohydrates/d) for 6 months
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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. | Change from baseline to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of a low-carb dietary intervention on body composition as measured with dual-energy x-ray absorptiometry | Change from baseline to 6 months | — |
| Effect of a low-carb dietary intervention on metabolomics as measured in plasma, urine and stool samples | 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 |
| Effect of a low-carb dietary intervention on gut microbiota composition as measured in stool samples | Change from baseline to 6 months | Human gut microbiota composition measured with metagenomic shotgun sequencing |
| Effect of a low-carb dietary Intervention on brain network activity as measured with functional MRI | Change from baseline to 6 months | — |
| Effect of a low-carb dietary intervention on liver fat fraction as measured with MRI | Change from baseline to 6 months | — |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORBettina Wölnerhanssen, MD
University Hospital, Basel, Switzerland
Outcome results
None listed