Appetite RegulationNCT01965210
The Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function
A study testing Rye + high dose inulin + low dose gluten, Rye + equal doses of inulin & gluten and Rye + low dose inulin + high dose gluten in people with Appetite Regulation, run by Swedish University of Agricultural Sciences at 1 site in Sweden.
Trial summary
Acute effects on appetite and metabolic function have been observed for whole-grain rye cereal products. The aim of this study is to evaluate if the appetite suppressing effect of a whole-grain rye breakfast cereal may be further enhanced by the addition of fermentable dietary fibre and plant protein. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite Regulation
- What is being tested?
- Rye + high dose inulin + low dose gluten, Rye + equal doses of inulin & gluten and Rye + low dose inulin + high dose gluten
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2013to Aug 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women must be post-menopausal or habitually take hormonal contraceptives
- Habitual breakfast eaters
Who cannot join
- Non-contraceptive use among pre-menopausal women
- Pregnancy, lactation or wishing to become pregnant during the study period
- Dieting
- Weightloss
- Eating disorder
- Hyperglycemic
Show all 16Show fewer
- Hyperinsulinemic
- Thyroid disease
- Metabolic issues
- Diabetes
- Physical or psychological problems eating
- Food intolerances/allergies to foods included in the study
- Vegetarians
- Intolerance/allergy to paracetamol
- Heavy smokers
- Recent or concurrent participation in an 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 Combined Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function After Short-Term Consumption
Acute effects on appetite and metabolic function have been observed for whole-grain rye cereal products. The aim of this study is to evaluate if the appetite suppressing effect of a whole-grain rye breakfast cereal may be further enhanced by the addition of fermentable dietary fibre and plant protein. The aim is also to try to elucidate how observed effects on subjective appetite are mediated in terms of changes in hormonal signals, flow of nutrients in the blood and products from bacterial fermentation of dietary fibre, and to relate this to the different composition of the breakfasts.
Read the detailed description
The short-term effects (up to 8 hours after intake) of dietary fibre and plant protein on subjective appetite and metabolism will be evaluated using a randomized cross-over study design. Each participant will consume six different breakfasts on six different occasions separated by a 1 week wash-out period: three rye porridges supplemented with three different combinations of added fermentable dietary fibre and plant protein, two non-supplemented rye porridges differing in amount of rye and one wheat bread. Participants will rate subjective appetite (satiety, hunger and desire to eat) by using a visual analog scale (VAS) every 30 min during an 8-hour period, starting 30 min before breakfast. The concentration of hydrogen and methane in the breath, as indicators of bacterial fermentation of dietary fibre, will be measured every hour. Blood samples will be collected before breakfast and at regular intervals throughout the day for analysis of glucose and hormone levels. The metabolic profile in the blood will be assessed as well as products from bacterial fermentation of dietary fibre, such as short chain fatty acids. Gastric emptying rate will also be evaluated using paracetamol as an indicator. Hormonal responses, changes in the metabolome and fermentation products will be related to subjective appetite and to differences in composition of the breakfasts.
- Conditions
- Appetite Regulation
- Being tested
- Rye + high dose inulin + low dose gluten, Rye + equal doses of inulin & gluten, Rye + low dose inulin + high dose gluten, Large non-supplemented rye, Small non-supplemented rye
- Keywords
- Rye, Fermentable dietary fibre, Inulin, Plant protein, Gluten, Porridge, Bread, Appetite, Satiety, Hunger, Desire to eat, Metabolism, Glucose, Insulin, Gut hormones, Metabolomics, Gastric emptying rate, Breath hydrogen and methane excretion
- 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 + high dose inulin + low dose glutenOther
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
Rye + equal doses of inulin & glutenOther
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
Rye + low dose inulin + high dose glutenOther
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
Large non-supplemented ryeOther
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
Small non-supplemented ryeOther
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
Refined wheat breadOther
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
| Study group | Role | What they receive |
|---|---|---|
| Rye + high dose inulin + low dose gluten | Experimental | Rye porridge supplemented with a high dose of the fermentable dietary fibre inulin and low dose of the plant protein gluten. Receives: Other: Rye + equal doses of inulin & gluten; Other: Rye + low dose inulin + high dose gluten; Other: Large non-supplemented rye; Other: Small non-supplemented rye; Other: Refined wheat bread |
| Rye + equal doses of inulin & gluten | Experimental | Rye porridge supplemented with equal doses of the fermentable dietary fibre inulin and the plant protein gluten. Receives: Other: Rye + high dose inulin + low dose gluten; Other: Rye + low dose inulin + high dose gluten; Other: Large non-supplemented rye; Other: Small non-supplemented rye; Other: Refined wheat bread |
| Rye + low dose inulin + high dose gluten | Experimental | Rye porridge supplemented with a low dose of the fermentable dietary fibre inulin and a high dose of the plant protein gluten. Receives: Other: Rye + high dose inulin + low dose gluten; Other: Rye + equal doses of inulin & gluten; Other: Large non-supplemented rye; Other: Small non-supplemented rye; Other: Refined wheat bread |
| Large non-supplemented rye | Experimental | Large portion of rye porridge without supplements. Receives: Other: Rye + high dose inulin + low dose gluten; Other: Rye + equal doses of inulin & gluten; Other: Rye + low dose inulin + high dose gluten; Other: Small non-supplemented rye; Other: Refined wheat bread |
| Small non-supplemented rye | Experimental | Small portion of rye porridge without supplements. Receives: Other: Rye + high dose inulin + low dose gluten; Other: Rye + equal doses of inulin & gluten; Other: Rye + low dose inulin + high dose gluten; Other: Large non-supplemented rye; Other: Refined wheat bread |
| Refined wheat bread | Active comparator | Refined wheat bread. Receives: Other: Rye + high dose inulin + low dose gluten; Other: Rye + equal doses of inulin & gluten; Other: Rye + low dose inulin + high dose gluten; Other: Large non-supplemented rye; Other: Small non-supplemented rye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective appetite profiles
Subjective feelings of appetite (satiety, hunger and desire to eat) are assessed by visual analogue scale (VAS) (in total 18 measurements).
Measured: 8 h (-30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480)
Secondary outcomes (6)
Breath hydrogen and methane response
Measurements of the concentration of breath hydrogen and methane(in total 10 measurements).
Measured: 8 h (-30, 30, 90, 150, 210, 270, 330, 390, 450, 480)
Gastric emptying rate
Paracetamol (1 g) was taken with breakfast. The appearance of paracetamol in the blood is directly related to the rate of gastric emptying.
Measured: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
Glucose and hormonal response
Glucose, insulin, 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: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
Metabolic profiles
The flux of nutrients is measured in plasma samples.
Measured: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
Products from bacterial fermentation of dietary fibre
Products from bacterial fermentation of dietary fibre are measured in plasma samples.
Measured: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
Ad libitum food intake
Energy intakes will be assessed from the ad libitum dinner in order to validate subjective appetite measurements.
Measured: 8 h after breakfast (480 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 22 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
- NCT01965210
- Sponsor's protocol ID
- SLU-IL-S1
- Status last verified
- Oct 2013
- First submitted
- 16 Sep 2013
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function After Short-Term Consumption
- ClinicalTrials.gov ID
- NCT01965210
- Acronym / sponsor ID
- SLU-IL-S1
- Conditions
- Appetite Regulation
- Keywords
- Rye, Fermentable dietary fibre, Inulin, Plant protein, Gluten, Porridge, Bread, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Swedish University of Agricultural SciencesUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 18 Oct 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.
Acute effects on appetite and metabolic function have been observed for whole-grain rye cereal products. The aim of this study is to evaluate if the appetite suppressing effect of a whole-grain rye breakfast cereal may be further enhanced by the addition of fermentable dietary fibre and plant protein. The aim is also to try to elucidate how observed effects on subjective appetite are mediated in terms of changes in hormonal signals, flow of nutrients in the blood and products from bacterial fermentation of dietary fibre, and to relate this to the different composition of the breakfasts.
Detailed description
The short-term effects (up to 8 hours after intake) of dietary fibre and plant protein on subjective appetite and metabolism will be evaluated using a randomized cross-over study design. Each participant will consume six different breakfasts on six different occasions separated by a 1 week wash-out period: three rye porridges supplemented with three different combinations of added fermentable dietary fibre and plant protein, two non-supplemented rye porridges differing in amount of rye and one wheat bread. Participants will rate subjective appetite (satiety, hunger and desire to eat) by using a visual analog scale (VAS) every 30 min during an 8-hour period, starting 30 min before breakfast. The concentration of hydrogen and methane in the breath, as indicators of bacterial fermentation of dietary fibre, will be measured every hour. Blood samples will be collected before breakfast and at regular intervals throughout the day for analysis of glucose and hormone levels. The metabolic profile in the blood will be assessed as well as products from bacterial fermentation of dietary fibre, such as short chain fatty acids. Gastric emptying rate will also be evaluated using paracetamol as an indicator. Hormonal responses, changes in the metabolome and fermentation products 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
- 6
| Arm | Type | Receives |
|---|---|---|
| Rye + high dose inulin + low dose gluten | Experimental | Other: Rye + equal doses of inulin & gluten, Other: Rye + low dose inulin + high dose gluten, Other: Large non-supplemented rye, Other: Small non-supplemented rye, Other: Refined wheat breadRye porridge supplemented with a high dose of the fermentable dietary fibre inulin and low dose of the plant protein gluten. |
| Rye + equal doses of inulin & gluten | Experimental | Other: Rye + high dose inulin + low dose gluten, Other: Rye + low dose inulin + high dose gluten, Other: Large non-supplemented rye, Other: Small non-supplemented rye, Other: Refined wheat breadRye porridge supplemented with equal doses of the fermentable dietary fibre inulin and the plant protein gluten. |
| Rye + low dose inulin + high dose gluten | Experimental | Other: Rye + high dose inulin + low dose gluten, Other: Rye + equal doses of inulin & gluten, Other: Large non-supplemented rye, Other: Small non-supplemented rye, Other: Refined wheat breadRye porridge supplemented with a low dose of the fermentable dietary fibre inulin and a high dose of the plant protein gluten. |
| Large non-supplemented rye | Experimental | Other: Rye + high dose inulin + low dose gluten, Other: Rye + equal doses of inulin & gluten, Other: Rye + low dose inulin + high dose gluten, Other: Small non-supplemented rye, Other: Refined wheat breadLarge portion of rye porridge without supplements. |
| Small non-supplemented rye | Experimental | Other: Rye + high dose inulin + low dose gluten, Other: Rye + equal doses of inulin & gluten, Other: Rye + low dose inulin + high dose gluten, Other: Large non-supplemented rye, Other: Refined wheat breadSmall portion of rye porridge without supplements. |
| Refined wheat bread | Active comparator | Other: Rye + high dose inulin + low dose gluten, Other: Rye + equal doses of inulin & gluten, Other: Rye + low dose inulin + high dose gluten, Other: Large non-supplemented rye, Other: Small non-supplemented ryeRefined wheat bread. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women must be post-menopausal or habitually take hormonal contraceptives
- Habitual breakfast eaters
Key exclusion criteria (16 listed)
- Non-contraceptive use among pre-menopausal women
- Pregnancy, lactation or wishing to become pregnant during the study period
- Dieting
- Weightloss
- Eating disorder
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 + high dose inulin + low dose glutenIn a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out. | Other | Large non-supplemented rye, Refined wheat bread, Rye + equal doses of inulin & gluten, Rye + low dose inulin + high dose gluten, Small non-supplemented rye |
| Rye + equal doses of inulin & glutenIn a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out. | Other | Large non-supplemented rye, Refined wheat bread, Rye + high dose inulin + low dose gluten, Rye + low dose inulin + high dose gluten, Small non-supplemented rye |
| Rye + low dose inulin + high dose glutenIn a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out. | Other | Large non-supplemented rye, Refined wheat bread, Rye + equal doses of inulin & gluten, Rye + high dose inulin + low dose gluten, Small non-supplemented rye |
| Large non-supplemented ryeIn a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out. | Other | Refined wheat bread, Rye + equal doses of inulin & gluten, Rye + high dose inulin + low dose gluten, Rye + low dose inulin + high dose gluten, Small non-supplemented rye |
| Small non-supplemented ryeIn a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out. | Other | Large non-supplemented rye, Refined wheat bread, Rye + equal doses of inulin & gluten, Rye + high dose inulin + low dose gluten, Rye + low dose inulin + high dose gluten |
| Refined wheat breadIn a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out. | Other | Large non-supplemented rye, Rye + equal doses of inulin & gluten, Rye + high dose inulin + low dose gluten, Rye + low dose inulin + high dose gluten, Small non-supplemented rye |
Primary outcome
Subjective appetite profiles
Time frame: 8 h (-30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480)
Subjective feelings of appetite (satiety, hunger and desire to eat) are assessed by visual analogue scale (VAS) (in total 18 measurements).
6 secondary outcomes
Breath hydrogen and methane response
Time frame: 8 h (-30, 30, 90, 150, 210, 270, 330, 390, 450, 480)
Gastric emptying rate
Time frame: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
Glucose and hormonal response
Time frame: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
Metabolic profiles
Time frame: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
Products from bacterial fermentation of dietary fibre
Time frame: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
Ad libitum food intake
Time frame: 8 h after breakfast (480 min)
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 22 Oct 2013.
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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 + high dose inulin + low dose gluten, Rye + equal doses of inulin & gluten and Rye + low dose inulin + high dose gluten 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 2 inclusion and 16 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 22 Oct 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 (time frame: 8 h (-30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480)). 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 22 Oct 2013.