Subjective Appetite and SatietyNCT02554162
Chewy Satiety - the Interplay Between Food Structure, Oral Processing and Satiety
A study testing Rye products with varying structures in people with Subjective Appetite and Satiety, run by VTT Technical Research Centre of Finland at 1 site in Finland.
Trial summary
This study examines if there are differences in satiety responses between structurally different wholegrain rye products. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Subjective Appetite and Satiety
- What is being tested?
- Rye products with varying structures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2015to Dec 2015
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.5-25 kg/m2
- Habit of eating breakfast
Who cannot join
- Significant changes in body weight (+ or - 4 kg) during the previous year
- Smoking
- Pregnant or lactating
- Missing teeth (except 3rd molars)
- Acute temporomandibular disorders (TMD)
- Dietary restrictions possibly affecting the study (celiac disease, allergies or aversions to cereal foods/high carbohydrate foods)
- Abnormal eating behaviour (according to EDDS (Eating Disorder Diagnostic Scale))
Trial locations and contacts
1 site in 1 country.
About this study
This study examines if there are differences in satiety responses between structurally different wholegrain rye products.
Read the detailed description
The study consists of a satiety trial and mastication trial. The satiety trial consists of five study visits. Five cereal products with berry soup are presented in random order for each subject serving one of them in each study visit (crossover study design). Each meal consists of rye product or wheat bread providing 190 kcal of energy and of 3 dl berry soup (3 dl) providing 140 kcal of energy. The participants are instructed to evaluate their satiety and related sensations before eating the test food, right after eating and then every 30 min until 210 min after breakfast consumption. The evaluated sensations are hunger, fullness, satiety, desire to eat and prospective food consumption ("How much would you be able to eat right now?"), "thirstiness", "mood", "vigourosness" and "pleasantness"."Pleasantness" will be evaluated only right after eating the test food.
Cereal food samples with 3-digit number codes will be offered to each participant in a random order in mastication trial. The study products are rye products with varying structures. First the participant is asked to evaluate the expected satiety of the product (How filling would you expect this portion to be on a scale from 0 (=not full at all) to 10 (=extremely full)). Secondly the same food will be served to the participant in three portions and the participant will be asked to masticate each portion until she considers it to be ready for swallowing. Instead of swallowing the bolus will be expectorated to a plastic container which is kept on ice. The mastication process is characterized by measuring electrical activity of facial muscles by electromyography (EMG). The mastication process will be video-recorded to support data handling.
- Conditions
- Subjective Appetite and Satiety
- Being tested
- Rye products with varying structures
- Keywords
- Satiety, appetite, wholegrain rye
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rye products with varying structuresOther
The satiating effect of rye products with various structures will be studied
| Study group | Role | What they receive |
|---|---|---|
| Extruded wholegrain rye flakes | Active comparator | Rye products with varying structures Receives: Other: Rye products with varying structures |
| Extruded wholegrain rye puffs | Active comparator | Rye products with varying structures Receives: Other: Rye products with varying structures |
| Fresh wholegrain rye bread | Active comparator | Rye products with varying structures Receives: Other: Rye products with varying structures |
| Wholegrain rye beverage | Active comparator | Rye products with varying structures Receives: Other: Rye products with varying structures |
| Fresh wheat bread | Active comparator | Rye products with varying structures Receives: Other: Rye products with varying structures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial satiety, assessed using 10 cm visual analogue scale (0=not at all, 10=Extremely)
Measured: In every 30 min until 210 min after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Appetite and SatietyStudies 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
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VTT Technical Research Centre of Finland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554162
- Sponsor's protocol ID
- Chewy
- Status last verified
- Dec 2015
- First submitted
- 17 Sep 2015
- Last updated
- 28 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chewy Satiety - the Interplay Between Food Structure, Oral Processing and Satiety
- ClinicalTrials.gov ID
- NCT02554162
- Acronym / sponsor ID
- Chewy
- Conditions
- Subjective Appetite and Satiety
- Keywords
- Satiety, appetite, wholegrain rye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VTT Technical Research Centre of FinlandUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Sep 2015 (estimated)
- 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.
This study examines if there are differences in satiety responses between structurally different wholegrain rye products.
Detailed description
The study consists of a satiety trial and mastication trial. The satiety trial consists of five study visits. Five cereal products with berry soup are presented in random order for each subject serving one of them in each study visit (crossover study design). Each meal consists of rye product or wheat bread providing 190 kcal of energy and of 3 dl berry soup (3 dl) providing 140 kcal of energy. The participants are instructed to evaluate their satiety and related sensations before eating the test food, right after eating and then every 30 min until 210 min after breakfast consumption. The evaluated sensations are hunger, fullness, satiety, desire to eat and prospective food consumption ("How much would you be able to eat right now?"), "thirstiness", "mood", "vigourosness" and "pleasantness"."Pleasantness" will be evaluated only right after eating the test food.
Cereal food samples with 3-digit number codes will be offered to each participant in a random order in mastication trial. The study products are rye products with varying structures. First the participant is asked to evaluate the expected satiety of the product (How filling would you expect this portion to be on a scale from 0 (=not full at all) to 10 (=extremely full)). Secondly the same food will be served to the participant in three portions and the participant will be asked to masticate each portion until she considers it to be ready for swallowing. Instead of swallowing the bolus will be expectorated to a plastic container which is kept on ice. The mastication process is characterized by measuring electrical activity of facial muscles by electromyography (EMG). The mastication process will be video-recorded to support data handling.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Extruded wholegrain rye flakes | Active comparator | Other: Rye products with varying structuresRye products with varying structures |
| Extruded wholegrain rye puffs | Active comparator | Other: Rye products with varying structuresRye products with varying structures |
| Fresh wholegrain rye bread | Active comparator | Other: Rye products with varying structuresRye products with varying structures |
| Wholegrain rye beverage | Active comparator | Other: Rye products with varying structuresRye products with varying structures |
| Fresh wheat bread | Active comparator | Other: Rye products with varying structuresRye products with varying structures |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18.5-25 kg/m2
- Habit of eating breakfast
Key exclusion criteria (7 listed)
- Significant changes in body weight (+ or - 4 kg) during the previous year
- Smoking
- Pregnant or lactating
- Missing teeth (except 3rd molars)
- Acute temporomandibular disorders (TMD)
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 |
|---|---|---|
| Rye products with varying structuresThe satiating effect of rye products with various structures will be studied | Other | Extruded wholegrain rye flakes, Extruded wholegrain rye puffs, Fresh wheat bread, Fresh wholegrain rye bread, Wholegrain rye beverage |
Primary outcome
Postprandial satiety, assessed using 10 cm visual analogue scale (0=not at all, 10=Extremely)
Time frame: In every 30 min until 210 min after consumption
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 28 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rye products with varying structures in people with Subjective Appetite and Satiety, run by VTT Technical Research Centre of Finland at 1 site in Finland.
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 2 inclusion and 7 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 28 Nov 2016. 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 Finland. 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?
Postprandial satiety, assessed using 10 cm visual analogue scale (0=not at all, 10=Extremely) (time frame: In every 30 min until 210 min after consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2016.