RecruitingNot ApplicableNCT04234373
Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot Trial
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
Sponsor
University Hospital, Basel, Switzerland
Enrollment
40 participants
Start Date
Jul 1, 2020
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 55 Years
Inclusion Criteria10
- 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 Criteria24
- 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.
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Interventions
OTHERLow Carb diet
Low Carb diet (max. 130g carbohydrates/d) for 6 months
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04234373
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