The importance of the gut-brain axis and the effect of a low-carbohydrate diet in overweight and depression
Résumé de l'étude
In this project, we will investigate the effects of a carbohydrate-reduced diet. Depressive disorders and overweight frequently occur together, and it is estimated that about one-third of all individuals with depression belong to the "metabolic", i.e., overweight subtype.
We are conducting this project to find out whether overweight and depressed patients can benefit from this dietary adjustment.
The study consists of a screening and 6 study days.
Through an application software (= "App", Application software), participants are trained and gradually adjust their diet until after about 2 months a maximum intake of 130g of carbohydrates per day is reached. Before and after this dietary change, which is to be maintained for a total of 6 months, numerous investigations are carried out. These include blood draws (vitamins and trace elements, blood fats, blood sugar, etc.), determination of body composition (fat percentage, muscle percentage), determination of liver fat percentage, and a functional examination of the brain using MRI (Magnetic Resonance Imaging), as well as stool samples to determine the composition of gut bacteria, questionnaires on gastrointestinal complaints and mental state.
(BASEC)
Intervention étudiée
The research project investigates the effect of a carbohydrate-reduced diet ("Low Carb") on metabolism and psyche.
(BASEC)
Maladie en cours d'investigation
Overweight
Diabetes
Depression
(BASEC)
This project is conducted in Switzerland (Basel) and Germany (Lübeck). In Switzerland, the following participants are included:
Control group:
Normal-weight individuals (i.e., BMI = Body Mass Index 19.0-24.9kg/m2), aged between 18 and 55 years and physically and mentally healthy (control group) or have depression (Depressed, Slim).
Overweight individuals:
Overweight individuals (i.e., BMI = Body Mass Index >30kg/m2), aged between 18 and 55 years and have elevated blood sugar levels (pre-diabetes or diabetes) without or with depression.
(BASEC)
Critères d'exclusion
Individuals who cannot participate include those who:
- are already on a carbohydrate-reduced diet or otherwise follow a special diet
- suffer from a mental illness
- regularly take stomach acid blockers
- regularly take probiotics or prebiotics (bacterial preparations for the gut)
(BASEC)
Lieu de l’étude
Bâle
(BASEC)
Sponsor
St. Clara Research Ltd at St. Claraspital Basel
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
PD Dr. med. Bettina Wölnerhanssen
+41616858585
bettina.woelnerhanssen@clutterclaraspital.chSt. Clara Forschung AG, Basel
(BASEC)
Informations générales
University Hospital, Basel, Switzerland,
0041616858585;0616858585
bettina.woelnerhanssen@unibas.ch; forschung@claraspital.ch(ICTRP)
Informations générales
University Hospital, Basel, Switzerland
(ICTRP)
Informations scientifiques
University Hospital, Basel, Switzerland,
0041616858585;0616858585
bettina.woelnerhanssen@unibas.ch; forschung@claraspital.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
09.12.2019
(BASEC)
Identifiant de l'essai ICTRP
NCT04234373 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Understanding gut-brain interactions and the effect of a low-carb dietary intervention in obese and depressive patients with and without glucose intolerance or diabetes: a pilot trial (BASEC)
Titre académique
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 (ICTRP)
Titre public
Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot Trial (ICTRP)
Maladie en cours d'investigation
Glucose IntoleranceObesity
(ICTRP)
Intervention étudiée
Other: Low Carb diet
(ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
(ICTRP)
Critères d'inclusion/exclusion
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.
(ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Effect of a low-carb dietary intervention on glycemic control as defined by blood glucose level at 2h after an oral glucose tolerance test.
(ICTRP)
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;Effect of a low-carb dietary intervention on gut microbiota composition as measured in stool samples;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
(ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Bettina W?lnerhanssen, MD;Bettina W?lnerhanssen, MD;Bettina W?lnerhanssen, MD, bettina.woelnerhanssen@unibas.ch; forschung@claraspital.ch, 0041616858585;0616858585, University Hospital, Basel, Switzerland, (ICTRP)
ID secondaires
LCP Obese (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT04234373 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible