HealthyNCT05252013
The Impact of Broad Bean Hull on Blood Glucose Control and Gut Health
A study testing Experimental: Bean Hull Bread and Experimental: Plain Bread in people with Healthy and Overweight, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
This study aims to assess the effects of broad bean hull (BBH) consumption on blood glucose and gut health. Broad bean (Vicia faba) is widely cultivated in Scotland, with the UK being the most significant European producer. The seed coat (hull or testa) is removed during broad bean processing. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight
- What is being tested?
- Experimental: Bean Hull Bread and Experimental: Plain Bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jan 2019to 31 Mar 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females
- Aged 18-75 years old.
- BMI 23-35 kg/m2
- HbA1c <6.5%
- Total cholesterol ≤ 7 mmol/l
Who cannot join
- Glucose 6 Phosphate Dehydrogenase deficiency
- Diagnosed for chronic diseases; thyroid disorders, metabolic/genetic diseases, diabetes and disorders of glycaemic control; cardiovascular disease; irritable and inflammatory bowel disorders.
- Women with polycystic ovaries syndrome (PCOS)
- Women who are lactating or breastfeeding, pregnant
- On prescription medications known to affect metabolism, including hormonal contraceptives and thyroid medications, and hormonal replacement therapy
- Have taken a course of antibiotics in the past four weeks
Show all 13Show fewer
- Allergic/intolerant to foods provided in the study
- Diagnosed for high blood pressure and on prescription medications such as Ramipril
- Alcohol and/or other substance abuse
- Smoking and the use of e-cigarettes, nicotine patches and nicotine gums
- Physically active at a competitive level
- Usually not consuming significantly more than five portions of fruits and vegetables per day
- Poor venous access
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen, Rowett Institute
Aberdeen, Aberdeen City, AB10 6JW
About this study
This study aims to assess the effects of broad bean hull (BBH) consumption on blood glucose and gut health. Broad bean (Vicia faba) is widely cultivated in Scotland, with the UK being the most significant European producer. The seed coat (hull or testa) is removed during broad bean processing. This is a significant secondary product that is largely discarded. Preliminary work showed that this material is comparable to wheat bran and is rich in fibre (49%) and protein (18%). Additionally, it showed a rich phytochemical profile and lower fat and carbohydrate content than wheat bran. Experiments also showed that BBH inhibited the activity of alpha-amylase and alpha-glucosidase enzymes, suggesting anti-diabetic properties. Overall, these results showed that BBH is a secondary crop product having potential as a functional food for humans. Therefore, the objective of this study is to assess in vivo in humans the physiological and functional effects of BBH. Using an acute phase randomised controlled crossover design, the study will assess how consuming BBH fortified breads affects plasma glucose and gut health. The study will recruit 18 volunteers, normal-overweight, aged 18-75 years, who habitually consume low amounts of fruits and vegetables (≤3 portions/day). The volunteers will attend two identical stand-alone intervention sessions lasting three days each following the screening. The order of the intervention sessions will be randomised. On the day before each intervention session, the participants will provide a baseline faecal sample and have a continuous glucose monitoring sensor (CGMS) attached. They will be also be given a standardised dinner. On the next morning, following a 10-12 hr fast, an indwelling antecubital cannula will be inserted, and a blood sample will be taken for measuring baseline levels of metabolites. The volunteers will be given a standardised portion of the BBH or control bread to consume, and further blood samples taken for the subsequent four hours. Breath samples will also be taken at the same time points for measuring gastric emptying. The volunteers will be provided with all the meals for the rest of the day and the subsequent two days. These will include two portions per day of either the BBH or control bread. The meals will be standardised for energy and macronutrients. The volunteers will be instructed to return to the Human Nutrition Unit on the fourth morning and provide a second faecal sample and remove the CGMS. Blood samples will be analysed for systemic bioavailability and metabolism of test meal components, glucose regulatory hormones and breath samples for quantifying gastric emptying. The faecal samples will be analysed for gut bioavailability and metabolism of test meal components, microbial counts, composition, and water content.
Read the detailed description
The study aims to confirm in vivo the effects of consuming broad bean hull on blood glucose control and gut health. Although in vitro evidence is promising, its benefits remain confirmed in vivo in humans. No studies have previously attempted to assess the impact of broad bean hull consumption on glycaemic and gut health outcomes in humans. Therefore, this study will be novel and provide useful information on the potential of using BBH as a functional food for human health.
From a health perspective, it is essential to establish the bioavailability and metabolism of dietary constituents in humans. Certain metabolites are absorbed early in the gastrointestinal tract, whereas others are transported to the colon, where they are extensively metabolised by the gut microbiota. This study will characterise the bioactive metabolites present in the plasma and faecal samples obtained. This will inform on their availability to the systemic circulation and their excretion profiles.
Using targeted quantitative analysis (LC-MS and GC-MS), metabolites and their in vivo concentrations will be measured. The principal metabolites analysed will be those produced by the phenylpropanoid pathway and protein and carbohydrate metabolism products. These will include derivatives and metabolites of the simple phenols, benzoic acids, phenolic acids, phenylacetic acids, phenypropionic acids, phenylpyruvic acids, phenyllactic acids, mandellic acids, phenolic dimers, acetophenones, benzaldehydes, cinnamaldehydes, benzyl alcohols, cinnamyl alcohols, indoles, isoflavones, coumarins, chalcones, flavanones, flavones, flavonols, anthocyanidins.
Furthermore, short-chain fatty acids will be analysed in the participants' faecal samples. It has been shown that many of these compounds are bioactive and exhibit anti-oxidant and anti-inflammatory activity at in vivo concentrations. Therefore, these studies will provide important information on bioavailability and metabolism and correlate the indices with health biomarkers.
In addition, compounds such as the carcinogenic heterocyclic amines, genotoxic nitrosamines, indoles, polyamines, bile acids, and other protein metabolites considered detrimental to human health will also be measured. It is likely, the carbohydrate and phytochemical content of plant proteins may also protect against the formation of these toxic and potentially carcinogenic protein by-products.
- Conditions
- Healthy, Overweight
- Being tested
- Experimental: Bean Hull Bread, Experimental: Plain Bread
- Keywords
- gut bioavailability, plasma metabolites, faecal metabolites, broad bean hull, high fibre, Vicia faba
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Bean Hull BreadOther
Also called Broad Bean Hull Bread
The bean hull bread will deliver 21.96 g of fibre. Volunteers will consume a roll of bean hull bread (155g/portion) served with 25g of raspberry jam.
Experimental: Plain BreadOther
Also called Control Bread
The control bread will deliver 4.53 g of fibre. Volunteers will consume a roll of plain bread (122g/portion) served with 25g of raspberry jam.
| Study group | Role | What they receive |
|---|---|---|
| Plain Bread | Placebo comparator | Participants will be attending the Human Nutrition Unit in the morning (day 1), following an overnight fast. Fasted blood samples will be taken and one portion of plain bread (122g) served with 25g of jam will be consumed by the volunteers. The meal will be consumed within 15 minutes and postprandial blood samples will be collected. Participants will be provided with the meals for the rest of the day to take away and for days 2 and 3. In total, they will consume 6 plain bread rolls on days 1, 2 and 3 (2 bread rolls/day). Receives: Other: Experimental: Plain Bread |
| Broad bean hull bread | Experimental | Participants will be attending the Human Nutrition Unit in the morning, following an overnight fast. Fasted blood samples will be taken and one portion of the bean hull bread (155g) served with 25g of jam will be consumed by the volunteers. The meal will be consumed within 15 minutes and postprandial blood samples will be collected. Participants will be provided with the meals for the rest of the day to take away and for days 2 and 3. In total, they will consume 6 bean hull bread rolls on days 1, 2 and 3 (2 bread rolls/day). Receives: Other: Experimental: Bean Hull Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma key bioactive metabolites following the control and bean hull bread consumption
The intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, which will be consumed within 15 minutes and blood samples will be collected postprandial over 4 hours.
For both the control and test diet, plasma markers of the principal metabolites produced by the phenylpropanoid pathway and products of protein and carbohydrate metabolism will be measured over 4-hour interval and compared with baseline.
Measured: over 4 hours
Plasma key bioactive metabolites following the control and bean hull bread consumption
The intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, which will be consumed within 15 minutes and blood samples will be collected on the day. The participants will be provided with plain/bean hull bread rolls to be consumed on day 1 (intervention day), days 2 and 3. Fasted blood samples will be measured on day 4.
The principal metabolites produced by the phenylpropanoid pathway and products of protein and carbohydrate metabolism following the 3 days consumption of the test and control diet will be measured in fasted plasma of day 4. These metabolites will be compared with the baseline (day 1) and between diets (day 4 vs day 4).
Measured: Day 4
Faecal key bioactive metabolites excretion
The intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, consumed within 15 minutes. Participants will also consume the plain/bean hull bread for days 1, 2, 3. A second faecal sample will be collected on day 4 to assess participants' gut bioavailability of key nutrients and bioactive following the chronic consumption of the plain/bean hull bread rolls.
The principal metabolites produced by the phenylpropanoid pathway and products of protein and carbohydrate metabolism following the 3 days consumption of the test and control diet will be measured in faecal samples of day 4. These metabolites will be compared with the baseline (day 1) and between diets (day 4 vs day 4).
Measured: Day 4 (post intervention)
Determine the effects of consumption bean hull fortified bread on Ghrelin levels
To investigate the effect of bean hull bread on ghrelin. The intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, which will be consumed within 15 minutes and blood samples will be collected on the day. Ghrelin levels will be measured over 4 hours following the consumption of the plain/bean hull bread rolls.
Measured: over 4 hours
Determine the effects of consumption bean hull fortified bread on GLP-1 levels
To investigate the effect of bean hull bread on the hormone GLP-1. The intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, which will be consumed within 15 minutes and blood samples will be collected on the day. GLP-1 levels will be measured over 4 hours following the consumption of the plain/bean hull bread rolls.
Measured: over 4 hours
Determine the effects of consumption bean hull fortified bread on glucagon
To investigate the effect of bean hull bread on the hormone glucagon. The intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, which will be consumed within 15 minutes and blood samples will be collected on the day. Glucagon levels will be over 4 hours following the consumption of the plain/bean hull bread rolls.
Measured: over 4 hours
Determine the effects of consumption bean hull fortified bread on PYY
To investigate the effect of bean hull bread on the hormone PYY. The intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, which will be consumed within 15 minutes and blood samples will be collected on the day. PYY levels will be measured over 4 hours following the consumption of the plain/bean hull bread rolls.
Measured: over 4 hours
Secondary outcomes (4)
Postprandial blood glucose responses (recording iAUC and AUC)
Measuring postprandial glucose levels following the test meals
Measured: Every 5 minutes for 4 hours using a continuous glucose monitor device
Postprandial insulin responses (recording iAUC and AUC)
Measuring postprandial insulin levels following the test meals
Measured: 4 hours and Day 4
Microbiota composition change
Changes in the composition of the microbiota will be based on next-generation sequence analysis of 16S rRNA (ribosomal ribonucleic acid) genes extracted from faecal samples provided by all volunteers
Measured: Day 1 and 4
Gastric emptying
Measuring gastric emptying rate following the consumption of the two test meals
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start31 Jan 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Model description
- Randomised controlled crossover non-blinded design
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madalina Neacsu, Principal investigator, m.neacsu@abdn.ac.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252013
- Sponsor's protocol ID
- 4667
- Status last verified
- Feb 2022
- First submitted
- 7 Dec 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Broad Bean Hull on Blood Glucose Control and Gut Health
- ClinicalTrials.gov ID
- NCT05252013
- Acronym / sponsor ID
- 4667
- Conditions
- Healthy, Overweight
- Keywords
- gut bioavailability, plasma metabolites, faecal metabolites, broad bean hull, high fibre, Vicia faba
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 23 Feb 2022 (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.
This study aims to assess the effects of broad bean hull (BBH) consumption on blood glucose and gut health. Broad bean (Vicia faba) is widely cultivated in Scotland, with the UK being the most significant European producer. The seed coat (hull or testa) is removed during broad bean processing. This is a significant secondary product that is largely discarded. Preliminary work showed that this material is comparable to wheat bran and is rich in fibre (49%) and protein (18%). Additionally, it showed a rich phytochemical profile and lower fat and carbohydrate content than wheat bran. Experiments also showed that BBH inhibited the activity of alpha-amylase and alpha-glucosidase enzymes, suggesting anti-diabetic properties. Overall, these results showed that BBH is a secondary crop product having potential as a functional food for humans. Therefore, the objective of this study is to assess in vivo in humans the physiological and functional effects of BBH. Using an acute phase randomised controlled crossover design, the study will assess how consuming BBH fortified breads affects plasma glucose and gut health. The study will recruit 18 volunteers, normal-overweight, aged 18-75 years, who habitually consume low amounts of fruits and vegetables (≤3 portions/day). The volunteers will attend two identical stand-alone intervention sessions lasting three days each following the screening. The order of the intervention sessions will be randomised. On the day before each intervention session, the participants will provide a baseline faecal sample and have a continuous glucose monitoring sensor (CGMS) attached. They will be also be given a standardised dinner. On the next morning, following a 10-12 hr fast, an indwelling antecubital cannula will be inserted, and a blood sample will be taken for measuring baseline levels of metabolites. The volunteers will be given a standardised portion of the BBH or control bread to consume, and further blood samples taken for the subsequent four hours. Breath samples will also be taken at the same time points for measuring gastric emptying. The volunteers will be provided with all the meals for the rest of the day and the subsequent two days. These will include two portions per day of either the BBH or control bread. The meals will be standardised for energy and macronutrients. The volunteers will be instructed to return to the Human Nutrition Unit on the fourth morning and provide a second faecal sample and remove the CGMS. Blood samples will be analysed for systemic bioavailability and metabolism of test meal components, glucose regulatory hormones and breath samples for quantifying gastric emptying. The faecal samples will be analysed for gut bioavailability and metabolism of test meal components, microbial counts, composition, and water content.
Detailed description
The study aims to confirm in vivo the effects of consuming broad bean hull on blood glucose control and gut health. Although in vitro evidence is promising, its benefits remain confirmed in vivo in humans. No studies have previously attempted to assess the impact of broad bean hull consumption on glycaemic and gut health outcomes in humans. Therefore, this study will be novel and provide useful information on the potential of using BBH as a functional food for human health.
From a health perspective, it is essential to establish the bioavailability and metabolism of dietary constituents in humans. Certain metabolites are absorbed early in the gastrointestinal tract, whereas others are transported to the colon, where they are extensively metabolised by the gut microbiota. This study will characterise the bioactive metabolites present in the plasma and faecal samples obtained. This will inform on their availability to the systemic circulation and their excretion profiles.
Using targeted quantitative analysis (LC-MS and GC-MS), metabolites and their in vivo concentrations will be measured. The principal metabolites analysed will be those produced by the phenylpropanoid pathway and protein and carbohydrate metabolism products. These will include derivatives and metabolites of the simple phenols, benzoic acids, phenolic acids, phenylacetic acids, phenypropionic acids, phenylpyruvic acids, phenyllactic acids, mandellic acids, phenolic dimers, acetophenones, benzaldehydes, cinnamaldehydes, benzyl alcohols, cinnamyl alcohols, indoles, isoflavones, coumarins, chalcones, flavanones, flavones, flavonols, anthocyanidins.
Furthermore, short-chain fatty acids will be analysed in the participants' faecal samples. It has been shown that many of these compounds are bioactive and exhibit anti-oxidant and anti-inflammatory activity at in vivo concentrations. Therefore, these studies will provide important information on bioavailability and metabolism and correlate the indices with health biomarkers.
In addition, compounds such as the carcinogenic heterocyclic amines, genotoxic nitrosamines, indoles, polyamines, bile acids, and other protein metabolites considered detrimental to human health will also be measured. It is likely, the carbohydrate and phytochemical content of plant proteins may also protect against the formation of these toxic and potentially carcinogenic protein by-products.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled crossover non-blinded design
| Arm | Type | Receives |
|---|---|---|
| Plain Bread | Placebo comparator | Other: Experimental: Plain BreadParticipants will be attending the Human Nutrition Unit in the morning (day 1), following an overnight fast. Fasted blood samples will be taken and one portion of plain bread (122g) served with 25g of jam will be consumed by the volunteers. The meal will be consumed within 15 minutes and postprandial blood samples will be collected. Participants will be provided with the meals for the rest of the day to take away and for days 2 and 3. In total, they will consume 6 plain bread rolls on days 1, 2 and 3 (2 bread rolls/day). |
| Broad bean hull bread | Experimental | Other: Experimental: Bean Hull BreadParticipants will be attending the Human Nutrition Unit in the morning, following an overnight fast. Fasted blood samples will be taken and one portion of the bean hull bread (155g) served with 25g of jam will be consumed by the volunteers. The meal will be consumed within 15 minutes and postprandial blood samples will be collected. Participants will be provided with the meals for the rest of the day to take away and for days 2 and 3. In total, they will consume 6 bean hull bread rolls on days 1, 2 and 3 (2 bread rolls/day). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy males and females
- Aged 18-75 years old.
- BMI 23-35 kg/m2
- HbA1c <6.5%
- Total cholesterol ≤ 7 mmol/l
Key exclusion criteria (13 listed)
- Glucose 6 Phosphate Dehydrogenase deficiency
- Diagnosed for chronic diseases; thyroid disorders, metabolic/genetic diseases, diabetes and disorders of glycaemic control; cardiovascular disease; irritable and inflammatory bowel disorders.
- Women with polycystic ovaries syndrome (PCOS)
- Women who are lactating or breastfeeding, pregnant
- On prescription medications known to affect metabolism, including hormonal contraceptives and thyroid medications, and hormonal replacement therapy
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 |
|---|---|---|
| Experimental: Bean Hull BreadAlso: Broad Bean Hull BreadThe bean hull bread will deliver 21.96 g of fibre. Volunteers will consume a roll of bean hull bread (155g/portion) served with 25g of raspberry jam. | Other | Broad bean hull bread |
| Experimental: Plain BreadAlso: Control BreadThe control bread will deliver 4.53 g of fibre. Volunteers will consume a roll of plain bread (122g/portion) served with 25g of raspberry jam. | Other | Plain Bread |
Primary outcome
Plasma key bioactive metabolites following the control and bean hull bread consumption
Time frame: over 4 hours
The intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, which will be consumed within 15 minutes and blood samples will be collected postprandial over 4 hours. For both the control and test diet, plasma markers of the principal metabolites produced by the phenylpropanoid pathway and products of protein and carbohydrate metabolism will be measured over 4-hour interval and compared with baseline.
Plasma key bioactive metabolites following the control and bean hull bread consumption
Time frame: Day 4
The intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, which will be consumed within 15 minutes and blood samples will be collected on the day. The participants will be provided with plain/bean hull bread rolls to be consumed on day 1 (intervention day), days 2 and 3. Fasted blood samples will be measured on day 4. The principal metabolites produced by the phenylpropanoid pathway and products of protein and carbohydrate metabolism following the 3 days consumption of the test and control diet will be measured in fasted plasma of day 4. These metabolites will be compared with the baseline (day 1) and between diets (day 4 vs day 4).
Faecal key bioactive metabolites excretion
Time frame: Day 4 (post intervention)
The intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, consumed within 15 minutes. Participants will also consume the plain/bean hull bread for days 1, 2, 3. A second faecal sample will be collected on day 4 to assess participants' gut bioavailability of key nutrients and bioactive following the chronic consumption of the plain/bean hull bread rolls. The principal metabolites produced by the phenylpropanoid pathway and products of protein and carbohydrate metabolism following the 3 days consumption of the test and control diet will be measured in faecal samples of day 4. These metabolites will be compared with the baseline (day 1) and between diets (day 4 vs day 4).
Determine the effects of consumption bean hull fortified bread on Ghrelin levels
Time frame: over 4 hours
To investigate the effect of bean hull bread on ghrelin. The intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, which will be consumed within 15 minutes and blood samples will be collected on the day. Ghrelin levels will be measured over 4 hours following the consumption of the plain/bean hull bread rolls.
Determine the effects of consumption bean hull fortified bread on GLP-1 levels
Time frame: over 4 hours
To investigate the effect of bean hull bread on the hormone GLP-1. The intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, which will be consumed within 15 minutes and blood samples will be collected on the day. GLP-1 levels will be measured over 4 hours following the consumption of the plain/bean hull bread rolls.
Determine the effects of consumption bean hull fortified bread on glucagon
Time frame: over 4 hours
To investigate the effect of bean hull bread on the hormone glucagon. The intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, which will be consumed within 15 minutes and blood samples will be collected on the day. Glucagon levels will be over 4 hours following the consumption of the plain/bean hull bread rolls.
Determine the effects of consumption bean hull fortified bread on PYY
Time frame: over 4 hours
To investigate the effect of bean hull bread on the hormone PYY. The intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, which will be consumed within 15 minutes and blood samples will be collected on the day. PYY levels will be measured over 4 hours following the consumption of the plain/bean hull bread rolls.
4 secondary outcomes
Postprandial blood glucose responses (recording iAUC and AUC)
Time frame: Every 5 minutes for 4 hours using a continuous glucose monitor device
Postprandial insulin responses (recording iAUC and AUC)
Time frame: 4 hours and Day 4
Microbiota composition change
Time frame: Day 1 and 4
Gastric emptying
Time frame: 4 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 23 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Madalina Neacsu principal investigator
m.neacsu@abdn.ac.uk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Bean Hull Bread and Experimental: Plain Bread in people with Healthy and Overweight, run by University of Aberdeen at 1 site in United Kingdom.
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 5 inclusion and 13 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 23 Feb 2022. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Plasma key bioactive metabolites following the control and bean hull bread consumption (time frame: over 4 hours). The study lists 7 primary outcomes in all. 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 23 Feb 2022.