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

Obesity Glucose Intolerance

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.