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

Study Overview
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Brief Summary
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The overall aim is to investigate whether there is a difference between methods when a standardized visual analogue scale is used to measure appetite in the home-setting compared to a monitored clinical setting. Furthermore, the intention is to investigate differences in appetite response between diets based on rye or wheat products, as well as the effects on postprandial metabolic response to such diets. Lastly, the effect of venous blood collection on subjective appetite response will be evaluated.

Detailed Description
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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 response to such diets. Lastly, the effect of venous blood collection on subjective appetite response will be evaluated. Participants will be complete 3 clinic-based appetite assessments and 2 home-based appetite assessments in random order. The intervention diets will include a fixed amount of rye or wheat cereal products (approx. 650 kcal) as part of a hypocaloric diet with 500 kcal deficit, irrespective of energy requirements of the individual. Participants will follow a standardized meal plan, incorporating intervention products according to their allocation. The meal plan will consist of a breakfast consisting of puffs with milk. The lunch will consist of tomato soup with crisp bread and cheese/jam, and afternoon snack will consist of crisp bread with cheese/jam. Finally, the dinner will consist of goulash soup with soft or crisp bread and jam/cheese. The participants will be provided with all foods needed for this meal plan. During the day participants will need to answer questions about their appetite every 30 minutes from 8:00 to 12:00 and every 60 minutes from 13:00 to 21:00. These questionnaires with VAS will provide data for the comparison of home-setting and monitored clinical setting as well as appetite response between diets. One out of the three clinic-based assessment days will include continues blood sampling throughout the day allowing evaluation of subjective appetite response on venous blood collection. Also, blood samples will be analyzed for concentration of appetite regulating hormones; glucagon-like peptide-1 (GLP-1), cholecystokinin (CCK) and ghrelin. Furthermore, insulin and triglyceride concentration will be measured as well as exploratory analysis of metabolome, short chain fatty acids (SCFA), epigenetics and gene expression analyses. Baseline fecal samples will be collected and analyzed for composition of the gut microbiome as well as short chain fatty acids (SCFA). Participants will wear a so-called continuous glucose monitors CGM allowing analysis of postprandial blood glucose throughout all 5 appetite assessment days. Measurement of physical activity will be done using Acti-Watches throughout the intervention.

Official Title
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Evaluation of Appetite Measure Visual Analogue Scales in Home-setting: VASA-home

Conditions
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Overweight and Obesity, Appetitive Behavior

Intervention / Treatment
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* Other: Wheat home-based appetite assessment
* Other: Rye home-based appetite assessment
* Other: Wheat clinic-based appetite assessment
* Other: Rye clinic-based appetite assessment
* Other: Rye/Wheat clinic-based appetite assessment with blood sampling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wheat home-based<br> | Other: Wheat home-based appetite assessment<br>* Home-based appetite assessment with diet based on wheat cereal products.<br>|
| Experimental: Rye home-based<br> | Other: Rye home-based appetite assessment<br>* Home-based appetite assessment with diet based on rye cereal products.<br>|
| Experimental: Rye clinic-based<br> | Other: Rye clinic-based appetite assessment<br>* Clinic-based appetite assessment with diet based on rye cereal products.<br>|
| Experimental: Wheat clinic-based<br> | Other: Wheat clinic-based appetite assessment<br>* Clinic-based appetite assessment with diet based on wheat cereal products.<br>|
| Experimental: Wheat/Rye clinic-based with blood sampling<br> | Other: Rye/Wheat clinic-based appetite assessment with blood sampling<br>* Clinic-based appetite assessment with diet based on rye or wheat cereal products and continuous blood sampling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite assessment: hunger | Appetite will be measured through visual analogue scales 1-100mm, filled in by the participants throughout the assessment days. | Throughout the appetite assessment days ,13 hours. | 
| Appetite assessment: fullness | Appetite will be measured through visual analogue scales 1-100mm, filled in by the participants throughout the assessment days. | Throughout the appetite assessment days ,13 hours. | 
| Appetite assessment: desire to eat | Appetite will be measured through visual analogue scales 1-100mm, filled in by the participants throughout the assessment days. | Throughout the appetite assessment days ,13 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Body weight is measured after an overnight fast. | Through study completion, an average of 5 weeks. | 
| Height | The participant is measured to the nearest 0.5 cm without shoes. | Height is measured at baseline. | 
| Continuous glucose measurement | Interstitial blood glucose will be measured continuously throughout the intervention with so called continuous glucose monitors CGM, and glucose data for all 5 appetite assessment days will be analyzed. | Throughout the appetite assessment days ,13 hours. | 
| Physical activity | Physical activity will be measured throughout the intervention using Acti-Watches. | Throughout the appetite assessment days ,13 hours. | 
| Postprandial glucose response | Postprandial blood samples will be analyzed. | Throughout the appetite assessment days ,13 hours. | 
| Gut microbiome | Fecal samples will be collected and analyzed for composition of the gut microbiome | Gut microbiome is measured at baseline. | 
| Effect of continous blood sampling on subjective appetite response | Appetite assessment measured through visual analogue scales will be compared between testdays at the clinic with and without continuous blood sampling. | Throughout the appetite assessment days ,13 hours. | 
| Investigate differences in appetite response between rye- and wheat-based diets | Appetite will be measured through visual analogue scales 1-100mm and scores from rye-based diets and wheat-based diets will be compared. | Throughout the appetite assessment days ,13 hours. | 
| Insulin | Postprandial blood samples will be analyzed. | Throughout the appetite assessment days ,13 hours. | 
| Glucagon-like peptide-1 (GLP-1) | Postprandial blood samples will be analyzed. | Throughout the appetite assessment days ,13 hours. | 
| Ghrelin | Postprandial blood samples will be analyzed. | Throughout the appetite assessment days ,13 hours. | 
| Cholecystokinin (CCK) | Postprandial blood samples will be analyzed. | Throughout the appetite assessment days ,13 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual analogue scale (VAS), Continuous glucose monitors (CGM)