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

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ClinicalTrials.gov Identifier: NCT04234373
Recruitment Status : Recruiting
First Posted : January 21, 2020
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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

Condition or disease Intervention/treatment Phase
Glucose Intolerance Obesity Other: Low Carb diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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

  3. 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

  4. Effect of a low-carb dietary Intervention on brain network activity as measured with functional MRI [ Time Frame: Change from baseline to 6 months ]
  5. Effect of a low-carb dietary intervention on liver fat fraction as measured with MRI [ Time Frame: Change from baseline to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04234373


Contacts
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Contact: Bettina Wölnerhanssen, MD 0041616858585 bettina.woelnerhanssen@unibas.ch
Contact: Anne Christin Meyer-Gerspach, MSc, PhD 0041616858585 annechristin.meyergerspach@unibas.ch

Locations
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Switzerland
St Clara Research Ltd, St Claraspital Basel Recruiting
Basel, Switzerland, 4002
Contact: Bettina Wölnerhanssen, MD    0616858585    forschung@claraspital.ch   
Contact: Valentine Bordier, MSc    0616858585    valentine.bordier@clarspital.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Bettina Wölnerhanssen, MD University Hospital, Basel, Switzerland
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04234373    
Other Study ID Numbers: LCP Obese
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases