Validation of Appetite Method Visual Analogue Scales in Home-setting: VASA-home
Condition: Overweight and Obesity; Appetitive Behavior
MeSH terms: Overweight
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Wheat home-based appetite assessment; Rye home-based appetite assessment; Wheat clinic-based appetite assessment; Rye clinic-based appetite assessment; Rye/Wheat clinic-based appetite assessment with blood sampling
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Home-based appetite assessment with diet based on wheat cereal products.; Home-based appetite assessment with diet based on rye cereal products.; Clinic-based appetite assessment with diet based on wheat cereal products.; Clinic-based appetite assessment with diet based on rye cereal products.; Clinic-based appetite assessment with diet based on rye or wheat cereal products and continuous blood sampling.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Visual analogue scale (VAS); Continuous glucose monitors (CGM)