Appetite RegulationS2RBAMNCT02011217
The Effects of Rye Crisp Bread on Appetite and Metabolic Function
A study testing Rye crisp bread A, Rye crisp bread B and Wheat crisp bread C in people with Appetite Regulation, run by Swedish University of Agricultural Sciences at 1 site in Sweden.
Trial summary
The aim of this study is to contribute to a better understanding of how dietary fibre in rye affects appetite and metabolic processes. We will evaluate how the intake of rye crisp breads affects appetite, insulin secretion and glucose levels in the blood in healthy humans. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite Regulation
- What is being tested?
- Rye crisp bread A, Rye crisp bread B and Wheat crisp bread C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2013to Sep 2013
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Habitual breakfast eaters
Who cannot join
- Pregnancy, lactation or wishing to become pregnant during the study period
- Dieting
- Weightloss
- Eating disorder
- Hyperglycemic
- Hyperinsulinemic
Show all 14Show fewer
- Thyroid disease
- Metabolic issues
- Diabetes
- Physical or psychological problems with eating
- Food intolerance/allergies to foods included in the study
- Intolerance/allergy to paracetamol
- Heavy smokers
- Recent or concurrent participation in a dietary intervention research study
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital
Uppsala, Uppsala County, SE-751 85
About this study
Official title: The Effects of Rye Crisp Bread on Subjective Appetite and Metabolic Function After Short-term Consumption
The aim of this study is to contribute to a better understanding of how dietary fibre in rye affects appetite and metabolic processes. We will evaluate how the intake of rye crisp breads affects appetite, insulin secretion and glucose levels in the blood in healthy humans. We will also investigate microstructural properties of the crisp breads with microscopy, as well as to characterize the food products with respect to the content of dietary fibre and certain bioactive compounds. The aim is also to try to elucidate how observed effects on appetite are related to changes in insulin and glucose levels, appetite related hormonal signals and microstructural properties to verify findings from previous studies.
Read the detailed description
The short-term effects (up to 4 hours after intake) of rye crisp breads on subjective appetite and metabolism will be evaluated using a randomized cross-over study design. Each participant will consume three different breakfasts consisting of two different rye crisp breads and one wheat crisp bread on three different occasions separated by a 1 week wash-out period. Participants will rate subjective appetite (satiety, hunger and desire to eat) by using a visual analogue scale (VAS) every 30 min during a 4-hour period, starting 30 min before breakfast. Blood samples will be collected before breakfast and at regular intervals throughout the day for analysis of glucose, insulin and hormone levels. Gastric emptying rate will also be evaluated using paracetamol as an indicator. Glucose and hormonal responses will be related to subjective appetite and to differences in composition of the breakfasts.
- Conditions
- Appetite Regulation
- Being tested
- Rye crisp bread A, Rye crisp bread B, Wheat crisp bread C
- Keywords
- Rye, Dietary Fibre, Bread, Crisp bread, Appetite, Satiety, Hunger, Desire to eat, Metabolism, Glucose, Insulin, Gut hormones, Gastric emptying rate
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rye crisp bread AOther
In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.
Rye crisp bread BOther
In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.
Wheat crisp bread COther
In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.
| Study group | Role | What they receive |
|---|---|---|
| Rye crisp bread A | Experimental | Not described Receives: Other: Rye crisp bread B; Other: Wheat crisp bread C |
| Rye crisp bread B | Experimental | Not described Receives: Other: Rye crisp bread A; Other: Wheat crisp bread C |
| Wheat crisp bread C | Experimental | Not described Receives: Other: Rye crisp bread A; Other: Rye crisp bread B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Appetite Profiles during 4 hours
Subjective feelings of appetite (satiety, hunger and desire to eat) assessed by visual analogue scale (VAS).
Measured: -30, 0, 30, 60, 90, 120, 150, 180, 210, 240 minutes
Secondary outcomes (3)
Gastric Emptying Rate during 4 hours
Paracetamol (1 g) taken with breakfast. The appearance of paracetamol in the blood is directly related to the rate of gastric emptying.
Measured: -15, 15, 35, 65, 95, 125, 185, 230 minutes
Hormonal Responses during 4 hours
Glucagon, glucagon-like peptide-1 (GLP-1), glucose-dependent insulino-tropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), leptin and ghrelin are measured in plasma samples.
Measured: -15, 15, 35, 65, 95, 125, 185, 230 minutes
Glucose and Insulin Responses during 4 hours
Glucose and insulin are measured in plasma samples.
Measured: -15, 15, 35, 65, 95, 125, 185, 230 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2013
- Study completionSep 2013
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 Appetite RegulationStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish University of Agricultural Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Principal investigator, Isabella Lee, Swedish University of Agricultural Sciences
- Investigators
- Rikard K Landberg, Ass. Prof., Principal investigator, Swedish University of Agricultural Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011217
- Sponsor's protocol ID
- SLU-IL-S2
- Acronym
- S2RBAM
- Status last verified
- Dec 2013
- First submitted
- 6 Nov 2013
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Johansson DP, Lee I, Riserus U, Langton M, Landberg R. Effects of unfermented and fermented whole grain rye crisp breads served as part of a standardized breakfast, on appetite and postprandial glucose and insulin responses: a randomized cross-over trial. PLoS One. 2015 Mar 31;10(3):e0122241. doi: 10.1371/journal.pone.0122241. eCollection 2015.
PubMed 25826373
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Rye Crisp Bread on Subjective Appetite and Metabolic Function After Short-term Consumption
- ClinicalTrials.gov ID
- NCT02011217
- Acronym / sponsor ID
- S2RBAM / SLU-IL-S2
- Conditions
- Appetite Regulation
- Keywords
- Rye, Dietary Fibre, Bread, Crisp bread, Appetite, Satiety, Hunger, Desire to eat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Swedish University of Agricultural SciencesUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- Aug 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 13 Dec 2013 (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.
The aim of this study is to contribute to a better understanding of how dietary fibre in rye affects appetite and metabolic processes. We will evaluate how the intake of rye crisp breads affects appetite, insulin secretion and glucose levels in the blood in healthy humans. We will also investigate microstructural properties of the crisp breads with microscopy, as well as to characterize the food products with respect to the content of dietary fibre and certain bioactive compounds. The aim is also to try to elucidate how observed effects on appetite are related to changes in insulin and glucose levels, appetite related hormonal signals and microstructural properties to verify findings from previous studies.
Detailed description
The short-term effects (up to 4 hours after intake) of rye crisp breads on subjective appetite and metabolism will be evaluated using a randomized cross-over study design. Each participant will consume three different breakfasts consisting of two different rye crisp breads and one wheat crisp bread on three different occasions separated by a 1 week wash-out period. Participants will rate subjective appetite (satiety, hunger and desire to eat) by using a visual analogue scale (VAS) every 30 min during a 4-hour period, starting 30 min before breakfast. Blood samples will be collected before breakfast and at regular intervals throughout the day for analysis of glucose, insulin and hormone levels. Gastric emptying rate will also be evaluated using paracetamol as an indicator. Glucose and hormonal responses will be related to subjective appetite and to differences in composition of the breakfasts.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rye crisp bread A | Experimental | Other: Rye crisp bread B, Other: Wheat crisp bread C |
| Rye crisp bread B | Experimental | Other: Rye crisp bread A, Other: Wheat crisp bread C |
| Wheat crisp bread C | Experimental | Other: Rye crisp bread A, Other: Rye crisp bread B |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Habitual breakfast eaters
Key exclusion criteria (14 listed)
- Pregnancy, lactation or wishing to become pregnant during the study period
- Dieting
- Weightloss
- Eating disorder
- Hyperglycemic
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 crisp bread AIn a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period. | Other | Rye crisp bread B, Wheat crisp bread C |
| Rye crisp bread BIn a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period. | Other | Rye crisp bread A, Wheat crisp bread C |
| Wheat crisp bread CIn a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period. | Other | Rye crisp bread A, Rye crisp bread B |
Primary outcome
Subjective Appetite Profiles during 4 hours
Time frame: -30, 0, 30, 60, 90, 120, 150, 180, 210, 240 minutes
Subjective feelings of appetite (satiety, hunger and desire to eat) assessed by visual analogue scale (VAS).
3 secondary outcomes
Gastric Emptying Rate during 4 hours
Time frame: -15, 15, 35, 65, 95, 125, 185, 230 minutes
Hormonal Responses during 4 hours
Time frame: -15, 15, 35, 65, 95, 125, 185, 230 minutes
Glucose and Insulin Responses during 4 hours
Time frame: -15, 15, 35, 65, 95, 125, 185, 230 minutes
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 13 Dec 2013.
- Derived from this study: PubMed 25826373Johansson DP, Lee I, Riserus U, Langton M, Landberg R. Effects of unfermented and fermented whole grain rye crisp breads served as part of a standardized breakfast, on appetite and postprandial glucose and insulin responses: a randomized cross-over trial. PLoS One. 2015 Mar 31;10(3):e0122241. doi: 10.1371/journal.pone.0122241. eCollection 2015.
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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 K Landberg, Ass. Prof. principal investigator
Swedish University of Agricultural Sciences
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 crisp bread A, Rye crisp bread B and Wheat crisp bread C in people with Appetite Regulation, run by Swedish University of Agricultural Sciences 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 1 inclusion and 14 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 13 Dec 2013. 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?
Subjective Appetite Profiles during 4 hours (time frame: -30, 0, 30, 60, 90, 120, 150, 180, 210, 240 minutes). 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 NCT02011217, 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 13 Dec 2013.