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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 December 2023
• Main ID: NCT04234373
• Date of registration: 09/01/2020
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Basel, Switzerland
• Public title: Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot Trial
• Scientific 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
• Date of first enrolment: July 1, 2020
• Target sample size: 40
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04234373
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Bettina Wölnerhanssen, MD

• Name: Bettina Wölnerhanssen, MD

• Name: Bettina Wölnerhanssen, MD
• Affiliation: University Hospital, Basel, Switzerland

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Glucose Intolerance

Intervention(s)

Other: Low Carb diet

Primary Outcome(s)

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(s)

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 gut microbiota composition as measured in stool samples [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]

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 metabolomics as measured in plasma, urine and stool samples [Time Frame: Change from baseline to 6 months]

Secondary ID(s)

LCP Obese

Source(s) of Monetary Support

Please refer to primary and secondary sponsors