Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot Trial (NCT04234373) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot Trial
Switzerland40 participantsStarted 2020-07-01
Plain-language 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
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 d…
What they're measuring
1
Effect of a low-carb dietary intervention on glycemic control as defined by blood glucose level at 2h after an oral glucose tolerance test.