Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot Trial

University Hospital Basel

Status: Enrolling

Conditions: Obesity; Glucose Intolerance

Treatments: Other: Low Carb diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04234373

LCP Obese

Details and patient eligibility

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Low Carb dietary Intervention

Experimental group

Treatment:

Other: Low Carb diet