Validation of Appetite Method Visual Analogue Scales in Home-setting: VASA-home
NCT ID: NCT05004584
Last Updated: 2021-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2021-08-31
2021-11-16
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Wheat home-based
Wheat home-based appetite assessment
Home-based appetite assessment with diet based on wheat cereal products.
Rye home-based
Rye home-based appetite assessment
Home-based appetite assessment with diet based on rye cereal products.
Rye clinic-based
Rye clinic-based appetite assessment
Clinic-based appetite assessment with diet based on rye cereal products.
Wheat clinic-based
Wheat clinic-based appetite assessment
Clinic-based appetite assessment with diet based on wheat cereal products.
Wheat/Rye clinic-based with blood sampling
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.
Interventions
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Wheat home-based appetite assessment
Home-based appetite assessment with diet based on wheat cereal products.
Rye home-based appetite assessment
Home-based appetite assessment with diet based on rye cereal products.
Wheat clinic-based appetite assessment
Clinic-based appetite assessment with diet based on wheat cereal products.
Rye clinic-based appetite assessment
Clinic-based appetite assessment with diet based on rye cereal products.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
70 Years
ALL
Yes
Sponsors
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Chalmers University of Technology
OTHER
Responsible Party
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Rikard Landberg
Head of division of Food and Nutrition Science, Professor Rikard Landberg,
Principal Investigators
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Rikard Landberg, Dr
Role: PRINCIPAL_INVESTIGATOR
Chalmers University of Technology
Locations
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University of Gothenburg, Department of Food and Nutrition and Sport Science
Gothenburg, , Sweden
Countries
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References
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Aberg S, Webb DL, Nordin E, Hellstrom PM, Landberg R. Postprandial Effects of Four Test Meals Containing Wholegrain Rye or Refined Wheat Foods on Circulating Incretins, Ghrelin, Glucose, and Inflammatory Markers. J Nutr. 2025 Jan;155(1):185-196. doi: 10.1016/j.tjnut.2024.10.046. Epub 2024 Nov 6.
Other Identifiers
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28220086
Identifier Type: -
Identifier Source: org_study_id