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 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 Wölnerhanssen, MD, Principal Investigator, University Hospital, Basel, Switzerland
  • Overall Contact(s)
    • Bettina Wölnerhanssen, MD, 0041616858585, bettina.woelnerhanssen@unibas.ch

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.