AppetiteNCT02793297
Effects of Sourdough Fermented Rye Crisp Bread on Appetite and Postprandial Metabolic Responses
A study testing refined wheat crisp bread, sourdough fermented rye crisp bread and unfermented rye crisp bread in people with Appetite, run by Swedish University of Agricultural Sciences.
Trial summary
The overall objective is to evaluate the impact of sourdough fermented crisp bread on effects on appetite and postprandial glucose and insulin responses. Beneficial effects on appetite and postprandial insulin responses have been observed, particularly for unfermented rye crisp breads in a previous study. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite
- What is being tested?
- refined wheat crisp bread, sourdough fermented rye crisp bread and unfermented rye crisp bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2016
- 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
- BMI 18.5-30 kg/m2
- fasting plasma glucose <6.0 mmol/L,
- fasting serum insulin <11 mE/L
- serum TSH <2.5 mIE/L
- plasma LDL <5.3 mmol/L
- fasting plasma triglycerides (p-TG) <1.8 mmol/L
- habitual consumption of breakfast, lunch and dinner
Who cannot join
- smokers
- use of medications likely to affect appetite
- medical conditions involving the gastrointestinal tract
- gluten intolerance or food allergies
- physical problems with eating
- dieting or self-reported fluctuations in body weight of more than 10% three months prior to screening recent participation in a dietary study
- pregnancy
- lactation
About this study
Official title: Effects of Sourdough Fermented Rye Crisp Bread on Appetite and Postprandial Metabolic Responses: A Randomized Cross-over Trial
The overall objective is to evaluate the impact of sourdough fermented crisp bread on effects on appetite and postprandial glucose and insulin responses. Beneficial effects on appetite and postprandial insulin responses have been observed, particularly for unfermented rye crisp breads in a previous study. In the present study, the investigators evaluated how the intake of sourdough fermented rye crisp breads vs. unfermented rye crisp bread as well as a control refined wheat crisp bread product may affect self-rated appetite and postprandial insulin and glucose responses in healthy men and women in a meal-study. The investigators characterized intervention products with regards to microstructural and chemical features in order to elucidate underlying mechanisms for potential effects observed on appetite and postprandial metabolic responses.
Read the detailed description
Two commercial whole grain rye crisp breads processed differently (unfermented and sourdough fermented) and a refined wheat control product were tested in the study. The rye crisp bread products contained similar ingredients. All products provide similar amounts of available carbohydrates (about 30g). The total amount of test product is about 50-60g.
The specific primary aim of the study: To conduct a short-term breakfast intervention study in humans (n = 24) to compare the effect of 2 high-fiber rye crisp bread products processed in different ways (sourdough fermented or unfermented) and a refined wheat control crisp bread as part of a normal breakfast on self-rated appetite, postprandial glucose and insulin concentrations. Difference in post-prandial insulin response between products is the primary endpoint.
Secondary aim (conducted if significant effects in the primary endpoint have been demonstrated): To assess changes in hormones and their relation to self-perceived satiety, hunger and desire to eat and to differences in chemical and microstructural composition of the tested foods.
- Conditions
- Appetite
- Being tested
- refined wheat crisp bread, sourdough fermented rye crisp bread, unfermented rye crisp bread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
refined wheat crisp breadOther
Refined wheat crisp bread (52 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g).
sourdough fermented rye crisp breadOther
Sourdough fermented rye crisp bread (59.4 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g).
unfermented rye crisp breadOther
Unfermented rye crisp bread (59.8 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g).
| Study group | Role | What they receive |
|---|---|---|
| refined wheat crisp bread | Experimental | refined wheat crisp bread was served as part of a complete standardized breakfast Receives: Other: refined wheat crisp bread |
| sourdough fermented rye crisp bread | Experimental | Sourdough fermented rye crisp bread was served as part of a complete standardized breakfast Receives: Other: sourdough fermented rye crisp bread |
| unfermented rye crisp bread | Experimental | Unfermented rye crisp bread was served as part of a complete standardized breakfast Receives: Other: unfermented rye crisp bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective appetite assessed using an electronic visual analogue scale
Participants recorded their subjective sensation of fullness and hunger using an electronic visual analogue scale
Measured: 360 min after breakfast
Secondary outcomes (3)
Glucose
Plasma levels
Measured: 230 minutes after breakfast
insulin
Plasma levels
Measured: 230 minutes after breakfast
GLP-1
Plasma levels
Measured: 230 minutes after breakfast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppetiteStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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, Dr. Rikard Landberg, Swedish University of Agricultural Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793297
- Sponsor's protocol ID
- Barilla2
- Status last verified
- Jun 2016
- First submitted
- 29 May 2016
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sourdough Fermented Rye Crisp Bread on Appetite and Postprandial Metabolic Responses: A Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT02793297
- Acronym / sponsor ID
- Barilla2
- Conditions
- Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Swedish University of Agricultural SciencesUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Jun 2016 (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 overall objective is to evaluate the impact of sourdough fermented crisp bread on effects on appetite and postprandial glucose and insulin responses. Beneficial effects on appetite and postprandial insulin responses have been observed, particularly for unfermented rye crisp breads in a previous study. In the present study, the investigators evaluated how the intake of sourdough fermented rye crisp breads vs. unfermented rye crisp bread as well as a control refined wheat crisp bread product may affect self-rated appetite and postprandial insulin and glucose responses in healthy men and women in a meal-study. The investigators characterized intervention products with regards to microstructural and chemical features in order to elucidate underlying mechanisms for potential effects observed on appetite and postprandial metabolic responses.
Detailed description
Two commercial whole grain rye crisp breads processed differently (unfermented and sourdough fermented) and a refined wheat control product were tested in the study. The rye crisp bread products contained similar ingredients. All products provide similar amounts of available carbohydrates (about 30g). The total amount of test product is about 50-60g.
The specific primary aim of the study: To conduct a short-term breakfast intervention study in humans (n = 24) to compare the effect of 2 high-fiber rye crisp bread products processed in different ways (sourdough fermented or unfermented) and a refined wheat control crisp bread as part of a normal breakfast on self-rated appetite, postprandial glucose and insulin concentrations. Difference in post-prandial insulin response between products is the primary endpoint.
Secondary aim (conducted if significant effects in the primary endpoint have been demonstrated): To assess changes in hormones and their relation to self-perceived satiety, hunger and desire to eat and to differences in chemical and microstructural composition of the tested foods.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| refined wheat crisp bread | Experimental | Other: refined wheat crisp breadrefined wheat crisp bread was served as part of a complete standardized breakfast |
| sourdough fermented rye crisp bread | Experimental | Other: sourdough fermented rye crisp breadSourdough fermented rye crisp bread was served as part of a complete standardized breakfast |
| unfermented rye crisp bread | Experimental | Other: unfermented rye crisp breadUnfermented rye crisp bread was served as part of a complete standardized breakfast |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BMI 18.5-30 kg/m2
- fasting plasma glucose <6.0 mmol/L,
- fasting serum insulin <11 mE/L
- serum TSH <2.5 mIE/L
- plasma LDL <5.3 mmol/L
Key exclusion criteria (8 listed)
- smokers
- use of medications likely to affect appetite
- medical conditions involving the gastrointestinal tract
- gluten intolerance or food allergies
- physical problems with eating
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 |
|---|---|---|
| refined wheat crisp breadRefined wheat crisp bread (52 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g). | Other | refined wheat crisp bread |
| sourdough fermented rye crisp breadSourdough fermented rye crisp bread (59.4 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g). | Other | sourdough fermented rye crisp bread |
| unfermented rye crisp breadUnfermented rye crisp bread (59.8 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g). | Other | unfermented rye crisp bread |
Primary outcome
Subjective appetite assessed using an electronic visual analogue scale
Time frame: 360 min after breakfast
Participants recorded their subjective sensation of fullness and hunger using an electronic visual analogue scale
3 secondary outcomes
Glucose
Time frame: 230 minutes after breakfast
insulin
Time frame: 230 minutes after breakfast
GLP-1
Time frame: 230 minutes after breakfast
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 9 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing refined wheat crisp bread, sourdough fermented rye crisp bread and unfermented rye crisp bread in people with Appetite, run by Swedish University of Agricultural Sciences.
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 7 inclusion and 8 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 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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 assessed using an electronic visual analogue scale (time frame: 360 min after breakfast). 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 9 Jun 2016.