Validation of Appetite Method Visual Analogue Scales in Home-setting: VASA-home

Launched by CHALMERS UNIVERSITY OF TECHNOLOGY · Aug 6, 2021

Keywords

ClinConnect Summary

A human dietary intervention study will be conducted at clinical facilities in Gothenburg. The study will be a randomized crossover trial where 30 overweight, but healthy men and women will be recruited. The overall aim is to investigate whether there is a difference between methods when a standardized visual analogue scale (VAS) is used to measure appetite in the home-setting compared to a monitored clinical setting. Furthermore, the intention is to investigate difference in appetite response between diets based on rye or wheat products, as well as the effects on postprandial metabolic res...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women
• • Age 30-70 years
• • Body mass index (BMI) 27-35 kg/m2
• • Hemoglobin ≥117g/l for women and for men ≥134g/l
• • Thyroid stimulating hormone (TSH) ≤4.30 mIU/L
• • Low density lipoprotein (LDL) cholesterol ≤5.30 mmol/L
• • Triglycerides ≤2.60 mmol/L
• • Signed informed consent
• • Having a mobile device, laptop or similar with internet connection. As well as an email, that they are willing to use for answering questions online, both at the clinic and at home.
• Exclusion Criteria:
• • Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
• • Using nicotine products on a daily basis (incl. chewing gum, patches, snus etc.)
• • Using e-cigarettes (regardless of nicotine content)
• • Following any weight reduction program or having followed one during the last 6 months prior to screening.
• • Diastolic blood pressure ≥ 105 mm Hg at screening
• • Systolic blood pressure ≥ 160 mm at screening
• • History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
• • More than 10 hours physical activity per week (e.g. sport, fitness or similar).
• • History of heart failure or heart attack within 1 year prior to screening
• • Having type-I diabetes
• • Receiving pharmacological treatment for type-II diabetes
• • Previous gastrointestinal surgery, with the exception of minor surgeries such removal of appendix or gall bladder at least 6 months prior to screening.
• • Thyroid disorder
• • History of drug or alcohol abuse
• • Stroke or transient ischemic attack (TIA) within 1 year prior to screening
• • Consumption of drugs aimed at weight management or drugs affecting body weight to a degree that is considered unsuitable for study participation by responsible physician.
• • Pregnant, lactation or planning a pregnancy within the timeframe of the study. Pregnancy must have ended at least 6 months prior to screening, and lactation must have ended at least 1 month prior to screening.
• • Food allergies, intolerances or dietary restrictions (e.g. vegetarian) preventing consumption of any products included in the study
• • Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personal.
• • Lack of suitability for participation in the study, for any reason, as judged by the medical doctor or PI.