|

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

RECRUITINGN/ASponsored by University Hospital, Basel, Switzerland
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital, Basel, Switzerland
Started2020-07-01
Est. completion2025-12
Eligibility
Age18 Years – 55 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04234373

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

Age: 18 Years – 55 YearsHealthy 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.

Conditions3

DiabetesGlucose IntoleranceObesity

Browse More Trials

Diabetes trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.