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

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2024

Interventions

  • Other: Low Carb diet
    • Low Carb diet (max. 130g carbohydrates/d) for 6 months

Arms, Groups and Cohorts

  • Experimental: Low Carb dietary Intervention

Clinical Trial Outcome Measures

Primary Measures

  • Effect of a low-carb dietary intervention on glycemic control as defined by blood glucose level at 2h after an oral glucose tolerance test.
    • Time Frame: Change from baseline to 6 months

Secondary Measures

  • Effect of a low-carb dietary intervention on body composition as measured with dual-energy x-ray absorptiometry
    • Time Frame: Change from baseline to 6 months
  • Effect of a low-carb dietary intervention on metabolomics as measured in plasma, urine and stool samples
    • Time Frame: Change from baseline to 6 months
    • Metabolomic analysis of the bacterial metabolites present in the urine by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry
  • Effect of a low-carb dietary intervention on gut microbiota composition as measured in stool samples
    • Time Frame: Change from baseline to 6 months
    • Human gut microbiota composition measured with metagenomic shotgun sequencing
  • Effect of a low-carb dietary Intervention on brain network activity as measured with functional MRI
    • Time Frame: Change from baseline to 6 months
  • Effect of a low-carb dietary intervention on liver fat fraction as measured with MRI
    • Time Frame: Change from baseline to 6 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Basel, Switzerland
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bettina W├Âlnerhanssen, MD, Principal Investigator, University Hospital, Basel, Switzerland
  • Overall Contact(s)
    • Bettina W├Âlnerhanssen, MD, 0041616858585, bettina.woelnerhanssen@unibas.ch

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