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

Recruiting
18 - 55 years of age
Both
Phase N/A

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Overview

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

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.

Study details

Glucose Intolerance, Obesity

NCT04234373

University Hospital, Basel, Switzerland

15 May 2024

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