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

Primary Purpose

Glucose Intolerance, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Low Carb diet
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glucose Intolerance

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • St Clara Research Ltd, St Claraspital BaselRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low Carb dietary Intervention

Arm Description

Outcomes

Primary Outcome 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.

Secondary Outcome Measures

Effect of a low-carb dietary intervention on body composition as measured with dual-energy x-ray absorptiometry
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
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
Effect of a low-carb dietary Intervention on brain network activity as measured with functional MRI
Effect of a low-carb dietary intervention on liver fat fraction as measured with MRI

Full Information

First Posted
January 9, 2020
Last Updated
November 7, 2022
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04234373
Brief Title
Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Carb dietary Intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Low Carb diet
Intervention Description
Low Carb diet (max. 130g carbohydrates/d) for 6 months
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Effect of a low-carb dietary intervention on metabolomics as measured in plasma, urine and stool samples
Description
Metabolomic analysis of the bacterial metabolites present in the urine by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry
Time Frame
Change from baseline to 6 months
Title
Effect of a low-carb dietary intervention on gut microbiota composition as measured in stool samples
Description
Human gut microbiota composition measured with metagenomic shotgun sequencing
Time Frame
Change from baseline to 6 months
Title
Effect of a low-carb dietary Intervention on brain network activity as measured with functional MRI
Time Frame
Change from baseline to 6 months
Title
Effect of a low-carb dietary intervention on liver fat fraction as measured with MRI
Time Frame
Change from baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bettina Wölnerhanssen, MD
Phone
0041616858585
Email
bettina.woelnerhanssen@unibas.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Christin Meyer-Gerspach, MSc, PhD
Phone
0041616858585
Email
annechristin.meyergerspach@unibas.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina Wölnerhanssen, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Clara Research Ltd, St Claraspital Basel
City
Basel
ZIP/Postal Code
4002
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bettina Wölnerhanssen, MD
Phone
0616858585
Email
forschung@claraspital.ch
First Name & Middle Initial & Last Name & Degree
Valentine Bordier, MSc
Phone
0616858585
Email
valentine.bordier@clarspital.ch

12. IPD Sharing Statement

Learn more about this trial

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

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