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

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

Study Overview

• Status: Recruiting
• Conditions: Obesity; Glucose Intolerance
• Intervention / Treatment: Other: Low Carb diet

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bettina Wölnerhanssen, MD; Phone Number: 0041616858585; Email: bettina.woelnerhanssen@unibas.ch
• Study Contact Backup: Name: Anne Christin Meyer-Gerspach, MSc, PhD; Phone Number: 0041616858585; Email: annechristin.meyergerspach@unibas.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4002
    • Recruiting
    • St Clara Research Ltd, St Claraspital Basel
    • Contact: Bettina Wölnerhanssen, MD; Phone Number: 0616858585; Email: forschung@claraspital.ch
    • Contact: Valentine Bordier, MSc; Phone Number: 0616858585; Email: valentine.bordier@clarspital.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Carb dietary Intervention	Other: Low Carb diet; Low Carb diet (max. 130g carbohydrates/d) for 6 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Bettina Wölnerhanssen, MD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: LCP Obese

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No