NCT05004584

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Chalmers University of Technology · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overweight and Obesity
• Appetitive Behavior

Interventions

Type	Name	Description
OTHER	Wheat home-based appetite assessment	Home-based appetite assessment with diet based on wheat cereal products.
OTHER	Rye home-based appetite assessment	Home-based appetite assessment with diet based on rye cereal products.
OTHER	Wheat clinic-based appetite assessment	Clinic-based appetite assessment with diet based on wheat cereal products.
OTHER	Rye clinic-based appetite assessment	Clinic-based appetite assessment with diet based on rye cereal products.
OTHER	Rye/Wheat clinic-based appetite assessment with blood sampling	Clinic-based appetite assessment with diet based on rye or wheat cereal products and continuous blood sampling.

Timeline

• Start date: 2021-08-31
• Primary completion: 2021-11-16
• Completion: 2021-11-16
• First posted: 2021-08-13
• Last updated: 2021-12-15

Locations

1 site across 1 country: Sweden