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

NCT05004584 | Completed

• 1 other identifier: 28220086
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and Obesity; Appetitive Behavior

Keywords

Visual analogue scale (VAS); Continuous glucose monitors (CGM)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Body weight

  Through study completion, an average of 5 weeks.

• Height

  Height is measured at baseline.

• Continuous glucose measurement

  Throughout the appetite assessment days ,13 hours.

• Physical activity

  Throughout the appetite assessment days ,13 hours.

• Postprandial glucose response

  Throughout the appetite assessment days ,13 hours.

Study Arms (5)

Wheat home-based

EXPERIMENTAL

Other: Wheat home-based appetite assessment

Rye home-based

EXPERIMENTAL

Other: Rye home-based appetite assessment

Rye clinic-based

EXPERIMENTAL

Other: Rye clinic-based appetite assessment

Wheat clinic-based

EXPERIMENTAL

Other: Wheat clinic-based appetite assessment

Wheat/Rye clinic-based with blood sampling

EXPERIMENTAL

Other: Rye/Wheat clinic-based appetite assessment with blood sampling

Interventions

Wheat home-based appetite assessment OTHER

Home-based appetite assessment with diet based on wheat cereal products.

Wheat home-based

Rye home-based appetite assessment OTHER

Home-based appetite assessment with diet based on rye cereal products.

Rye home-based

Wheat clinic-based appetite assessment OTHER

Clinic-based appetite assessment with diet based on wheat cereal products.

Wheat clinic-based

Rye clinic-based appetite assessment OTHER

Clinic-based appetite assessment with diet based on rye cereal products.

Rye clinic-based

Rye/Wheat clinic-based appetite assessment with blood sampling OTHER

Clinic-based appetite assessment with diet based on rye or wheat cereal products and continuous blood sampling.

Wheat/Rye clinic-based with blood sampling

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chalmers University of Technology: lead

Study Sites (1)

University of Gothenburg, Department of Food and Nutrition and Sport Science

Gothenburg, 41251, Sweden

Location

Related Publications (1)

• 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.

  PMID: 39515756 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Appetitive Behavior

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rikard Landberg, Dr

  Chalmers University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of division of Food and Nutrition Science, Professor Rikard Landberg,

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 13, 2021
• Study Start: August 31, 2021
• Primary Completion: November 16, 2021
• Study Completion: November 16, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-12

Locations

SE (1)