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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04234373
• Other study ID #: LCP Obese
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Bettina Wölnerhanssen, MD
• Phone: 0041616858585
• Email: bettina.woelnerhanssen[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Obesity

Intervention

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

Locations

Country	Name	City	State
Switzerland	St Clara Research Ltd, St Claraspital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effect of a low-carb dietary intervention on body composition as measured with dual-energy x-ray absorptiometry		Change from baseline to 6 months
Secondary	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
Secondary	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
Secondary	Effect of a low-carb dietary Intervention on brain network activity as measured with functional MRI		Change from baseline to 6 months
Secondary	Effect of a low-carb dietary intervention on liver fat fraction as measured with MRI		Change from baseline to 6 months