Clinical trial NCT04234373: Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot Trial
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glucose Intolerance
Obesity
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
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.
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Effect of a low-carb dietary intervention on body composition as measured with dual-energy x-ray absorptiometry
timeFrame: Change from baseline to 6 months
measure: Effect of a low-carb dietary intervention on metabolomics as measured in plasma, urine and stool samples
timeFrame: Change from baseline to 6 months
measure: Effect of a low-carb dietary intervention on gut microbiota composition as measured in stool samples
timeFrame: Change from baseline to 6 months
measure: Effect of a low-carb dietary Intervention on brain network activity as measured with functional MRI
timeFrame: Change from baseline to 6 months
measure: Effect of a low-carb dietary intervention on liver fat fraction as measured with MRI
timeFrame: Change from baseline to 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St Clara Research Ltd, St Claraspital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Bettina Wölnerhanssen, MD
role: PRINCIPAL_INVESTIGATOR
References: