💬In plain words
What the trial is, and whether it could suit you
The overall objective of this study is to evaluate the effectiveness of an optimized lifestyle intervention based on dietary advice, behavioral support, and provision of key foods compared to dietary advice with behavioral support or dietary advice alone. The intervention aims to improve nutritional status, metabolic risk factors, and planetary sustainability.
A total of 300 participants (150 men and 150 women) who meet all inclusion criteria and none of the exclusion criteria will be recruited. The study will be conducted at the Centre for Lifestyle Intervention at Östra Hospital in Gothenburg, led by researchers from Chalmers University of Technology, University of Gothenburg, and Sahlgrenska University Hospital. Participants will be recruited from two different socioeconomic areas in Gothenburg to examine how dietary interventions function in diverse population groups.
The study fol
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Age 18-70 years
* Body mass index 25-35 kg/m2
* Stable dietary patterns at the entry to the study (no specific dieting the last 4 weeks).
* Willingness to adhere to advised diet pattern and to consume provided key foods.
* Medications stable for the previous 14 days of relevant medicines
* Access to a -18⁰ C freezer to store key foods at home.
* Signed informed consent
Exclusion Criteria:
* Currently having an infection or other relevant illness.
* Cardiovascular events (myocardial infarction or stroke) during the previous 6 months. To be included, the disease needs to be stable.
* Diagnosis of diabetes (any type).
* Blood Pressure (BP): ≥185/105 mmHg.
* Serum Cholesterol (S-Chol): ≥8 mmol/L.
* Blood Glucose (B-Glucose): fasting value \>7 mmol/L.
* Currently on GLP-1 receptor agonists.
* History of stomach or gastrointestinal diagnoses (inflammatory bowel disease, Crohn's disease, hepatitis, malabsorption, celiac disease etc.).
* IBS- if severe and recent (\<0.5year)?
* Previous colostomy, bowel resection, bariatric surgery or other major gastrointestinal surgery.
* Renal or liver failure (creatinine \<1.7 mg/dl and alanine aminotransferase/ aspartate aminotransferase \> 2 times than normal values (ASAT, ALAT), respectively).
* Anemia or Hemoglobin (Hb): \<100 g/L
* Blood donation (or participation in a clinical study with blood sampling) within 30 days prior to inclusion
* Currently on a specific diet.
* A diet incompatible with protocol diets such as strict vegan/vegetarian.
* Food allergies or intolerances to food items included in the intervention.
* High level of regular physical activity at baseline - scale 4 on SG-PALS.
* History of drug or alcohol abuse.
* Not able to understand written or spoken Swedish.
* Any other reason for lack of suitability for participation in the trial, as judged by the principal investor and/ or the clinical investigator.
* Pregnant or lactating or planning to become pregnant during the study period.
* Involved in another potentially interfering research study.
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