Overweight and ObesityVASA-homeNCT05004584
Validation of Appetite Method Visual Analogue Scales in Home-setting: VASA-home
A study testing Wheat home-based appetite assessment, Rye home-based appetite assessment and Wheat clinic-based appetite assessment in people with Overweight and Obesity and Appetitive Behavior, run by Chalmers University of Technology at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Appetitive Behavior
- What is being tested?
- Wheat home-based appetite assessment, Rye home-based appetite assessment and Wheat clinic-based appetite assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSweden
- Study dates
- 31 Aug 2021to 16 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University of Gothenburg, Department of Food and Nutrition and Sport Science
Gothenburg, 41251
About this study
Official title: Evaluation of Appetite Measure Visual Analogue Scales in Home-setting: VASA-home
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.
Read the 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
- Being tested
- 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
- Keywords
- Visual analogue scale (VAS), Continuous glucose monitors (CGM)
- Medical subject headings
- Overweight, Obesity, Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat home-based appetite assessmentOther
Home-based appetite assessment with diet based on wheat cereal products.
Rye home-based appetite assessmentOther
Home-based appetite assessment with diet based on rye cereal products.
Wheat clinic-based appetite assessmentOther
Clinic-based appetite assessment with diet based on wheat cereal products.
Rye clinic-based appetite assessmentOther
Clinic-based appetite assessment with diet based on rye cereal products.
Rye/Wheat clinic-based appetite assessment with blood samplingOther
Clinic-based appetite assessment with diet based on rye or wheat cereal products and continuous blood sampling.
| Study group | Role | What they receive |
|---|---|---|
| Wheat home-based | Experimental | Not described Receives: Other: Wheat home-based appetite assessment |
| Rye home-based | Experimental | Not described Receives: Other: Rye home-based appetite assessment |
| Rye clinic-based | Experimental | Not described Receives: Other: Rye clinic-based appetite assessment |
| Wheat clinic-based | Experimental | Not described Receives: Other: Wheat clinic-based appetite assessment |
| Wheat/Rye clinic-based with blood sampling | Experimental | Not described Receives: Other: Rye/Wheat clinic-based appetite assessment with blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite assessment: hunger
Appetite will be measured through visual analogue scales 1-100mm, filled in by the participants throughout the assessment days.
Measured: 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.
Measured: 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.
Measured: Throughout the appetite assessment days ,13 hours.
Secondary outcomes (12)
Body weight
Body weight is measured after an overnight fast.
Measured: Through study completion, an average of 5 weeks.
Height
The participant is measured to the nearest 0.5 cm without shoes.
Measured: 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.
Measured: Throughout the appetite assessment days ,13 hours.
Physical activity
Physical activity will be measured throughout the intervention using Acti-Watches.
Measured: Throughout the appetite assessment days ,13 hours.
Postprandial glucose response
Postprandial blood samples will be analyzed.
Measured: Throughout the appetite assessment days ,13 hours.
Gut microbiome
Fecal samples will be collected and analyzed for composition of the gut microbiome
Measured: 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.
Measured: 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.
Measured: Throughout the appetite assessment days ,13 hours.
Insulin
Postprandial blood samples will be analyzed.
Measured: Throughout the appetite assessment days ,13 hours.
Glucagon-like peptide-1 (GLP-1)
Postprandial blood samples will be analyzed.
Measured: Throughout the appetite assessment days ,13 hours.
Ghrelin
Postprandial blood samples will be analyzed.
Measured: Throughout the appetite assessment days ,13 hours.
Cholecystokinin (CCK)
Postprandial blood samples will be analyzed.
Measured: Throughout the appetite assessment days ,13 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start31 Aug 2021
- Primary completion16 Nov 2021
- Study completion16 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikard Landberg, Chalmers University of Technology
- Investigators
- Rikard Landberg, Dr, Principal investigator, Chalmers University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004584
- Sponsor's protocol ID
- 28220086
- Acronym
- VASA-home
- Status last verified
- Dec 2021
- First submitted
- 16 Jul 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39515756
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Appetite Measure Visual Analogue Scales in Home-setting: VASA-home
- ClinicalTrials.gov ID
- NCT05004584
- Acronym / sponsor ID
- VASA-home / 28220086
- Conditions
- Overweight and Obesity, Appetitive Behavior
- Keywords
- Visual analogue scale (VAS), Continuous glucose monitors (CGM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheat home-based appetite assessmentHome-based appetite assessment with diet based on wheat cereal products. | Other | Wheat home-based |
| Rye home-based appetite assessmentHome-based appetite assessment with diet based on rye cereal products. | Other | Rye home-based |
| Wheat clinic-based appetite assessmentClinic-based appetite assessment with diet based on wheat cereal products. | Other | Wheat clinic-based |
| Rye clinic-based appetite assessmentClinic-based appetite assessment with diet based on rye cereal products. | Other | Rye clinic-based |
| Rye/Wheat clinic-based appetite assessment with blood samplingClinic-based appetite assessment with diet based on rye or wheat cereal products and continuous blood sampling. | Other | Wheat/Rye clinic-based with blood sampling |
Primary outcome
Appetite assessment: hunger
Time frame: Throughout the appetite assessment days ,13 hours.
Appetite will be measured through visual analogue scales 1-100mm, filled in by the participants throughout the assessment days.
Appetite assessment: fullness
Time frame: Throughout the appetite assessment days ,13 hours.
Appetite will be measured through visual analogue scales 1-100mm, filled in by the participants throughout the assessment days.
Appetite assessment: desire to eat
Time frame: Throughout the appetite assessment days ,13 hours.
Appetite will be measured through visual analogue scales 1-100mm, filled in by the participants throughout the assessment days.
12 secondary outcomes
Body weight
Time frame: Through study completion, an average of 5 weeks.
Height
Time frame: Height is measured at baseline.
Continuous glucose measurement
Time frame: Throughout the appetite assessment days ,13 hours.
Physical activity
Time frame: Throughout the appetite assessment days ,13 hours.
Postprandial glucose response
Time frame: Throughout the appetite assessment days ,13 hours.
Gut microbiome
Time frame: Gut microbiome is measured at baseline.
Effect of continous blood sampling on subjective appetite response
Time frame: Throughout the appetite assessment days ,13 hours.
Investigate differences in appetite response between rye- and wheat-based diets
Time frame: Throughout the appetite assessment days ,13 hours.
Insulin
Time frame: Throughout the appetite assessment days ,13 hours.
Glucagon-like peptide-1 (GLP-1)
Time frame: Throughout the appetite assessment days ,13 hours.
Ghrelin
Time frame: Throughout the appetite assessment days ,13 hours.
Cholecystokinin (CCK)
Time frame: Throughout the appetite assessment days ,13 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Derived from this study: PubMed 39515756Aberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rikard Landberg, Dr principal investigator
Chalmers University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheat home-based appetite assessment, Rye home-based appetite assessment and Wheat clinic-based appetite assessment in people with Overweight and Obesity and Appetitive Behavior, run by Chalmers University of Technology at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite assessment: hunger (time frame: Throughout the appetite assessment days ,13 hours.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05004584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.