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Clinical Trials in Switzerland / NCT04234373
Active, not recruiting Not applicable

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

NCT04234373 · tracked via the Priya Life Science Switzerland tracker
Phase
Not applicable
Started
2020-07-01
Last updated
2026-05-04

Condition(s) studied

Glucose IntoleranceObesity

Investigational drug(s) / intervention(s)

Low Carb diet

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

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
St Clara Research Ltd, St Claraspital Basel Basel Switzerland

More University Hospital, Basel, Switzerland trials in Switzerland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04234373 on ClinicalTrials.gov ↗ ← All trials in Switzerland