HealthyHYFFINCT02608983
Hydrocolloids as Functional Food Ingredients for Gut Health
A study testing Agar H1CC2013, Agar H1CC2012 and Maltodextrin in people with Healthy, run by University of Ulster.
Trial summary
Seaweeds are a natural source of nutrients, and dependent on the variety, are rich in dietary fibre, proteins, essential vitamins and minerals. However this resource is highly underexploited. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Agar H1CC2013, Agar H1CC2012 and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Dec 2010
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals
- Age 18-55 years
- Non smoking
- BMI >20 and <35kg/m2
Who cannot join
- Smoker
- Pregnant and lactating women
- Vegetarians and vegans
- Lactose intolerant individuals
- Diabetes
- Cardiovascular disease
Show all 12Show fewer
- Autoimmune/ inflammatory disorders
- History of neoplasm
- Recent acute illness and/or chronic prescribed or self-prescribed use of anti-inflammatory agents (including aspirin)
- Use of broad spectrum antibiotics
- Use of drugs active on gastrointestinal motility or laxatives
- Use of dietary supplements (specifically probiotics or prebiotics)
About this study
Seaweeds are a natural source of nutrients, and dependent on the variety, are rich in dietary fibre, proteins, essential vitamins and minerals. However this resource is highly underexploited. Countries such as Japan, China, North and South Korea are large consumers of edible seaweed while exposure in Western countries is much lower and mainly as industrially extracted seaweed derivatives, a common additive in many food and healthcare products. Seaweeds have been associated with a number of human gut promoting health benefits such as decreasing faecal transit time through the gastrointestinal tract thus preventing constipation and resulting in a reduced exposure to harmful substances (decreasing colon cancer risk). These health benefits can be attributed to seaweeds high dietary fibre content. Interestingly, the food and healthcare industry already utilize seaweed-extracted fibre in the manufacturing process thus steering the way forward towards the development of novel functional food products. These seaweed-extracted fibres are high molecular weight polysaccharides known as hydrocolloids and are non-digestible by humans, hence classified as dietary fibre.
Traditionally, seaweed derived polysaccharides (hydrocolloids) have been used to provide thickening and gelling functionality to food stuffs and other industrial applications however there is emerging evidence to show that lower molecular weight polysaccharides and oligosaccharides derived from these hydrocolloids can also act as a source of soluble fibre and may have prebiotic activity. Recent developments in Japan and Korea have lead to the commercial availability of products containing low molecular weight seaweed derived fibre. There is also some evidence for the beneficial effects of seaweed derived fibre in other key health areas such as cardiovascular health, cancer, diabetes and obesity. However, relatively little is known about the chemical, physio-chemical and fermentation characteristics of seaweed fibre in the human gut. Some hydrocolloids, notably guar gum (plant source), have also been employed for their health promoting properties in the areas of glucose tolerance and cholesterol lowering. However the use of hydrocolloids as functional food ingredients with health benefits for consumers has been rather limited and has focused more on uses in products for diabetics.
Read more
It is particularly in the area of gut health that small and medium-sized enterprises (SMEs) involved in hydrocolloid production and processing, can enter the functional food ingredients market by using innovative processing technology. The total dietary fibre content of seaweed can be as high as 75% of the total dry weight and a high proportion of this is soluble. The fibre component essentially comprises the structural polysaccharides i.e. alginate and fucoidan in brown seaweeds, carrageenan, agar and porphyran in red seaweeds and ulvan in green seaweeds. As these fibres are primarily soluble, they form viscous gels as they pass through the gastrointestinal tract. Some of the fibre is fermented in the lower intestine but in general, soluble and insoluble seaweed fibre tends to pass through the gut without being digested. In its natural form as part of the seaweed plant, this fibre is typically high in molecular weight and passes through the gut too rapidly for the gut microflora to utilize it to any great extent. There is therefore a necessity to develop lower molecular weight forms that are more soluble and can be added at higher concentrations to food products without affecting the sensory properties of the product.
The overall aim of the project is to realize an opportunity to produce low molecular weight polysaccharides (LMWP) from alginate- and agar-bearing seaweeds for applications in food \& health. The two effective agar and alginate LMWPs, identified by in vitro studies, will be selected for assessment of prebiotic activity in a feeding trial in human volunteers (Ulster University) as part of an European Union (EU) study. The end points to be assessed will be stimulation of beneficial bacteria (bifidogenic effects), increased short chain fatty acid production, beneficial effects on stool formation, and improvements in gut barrier function. Additionally, benefits of the LMWPs towards blood glucose levels (short term and acute) will be assessed.
- Conditions
- Healthy
- Being tested
- Agar H1CC2013, Agar H1CC2012, Maltodextrin
- Keywords
- Seaweed, Hydrocolloid, Functional Food, Dietary Fibre, Prebiotic, Low molecular weight polysaccharides, Alginate, Agar, HYFFI, Low molecular weight seaweed derived hydrocolloids as functional food ingredients, subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agar H1CC2013Dietary supplement
Following a 28-day washout one 250ml drink / day containing 8g of agar H1CC2013 as part of normal diet for 28 days
Agar H1CC2012Dietary supplement
Following a 28-day washout one 250ml drink / day containing 8g of agar H1CC2012 as part of normal diet for 28 days
MaltodextrinDietary supplement
Following a 28-day washout one 250ml drink / day containing 8g of maltodextrin as part of normal diet for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Not described Receives: Dietary Supplement: Agar H1CC2013 |
| Treatment 2 | Experimental | Not described Receives: Dietary Supplement: Agar H1CC2012 |
| Treatment 3 | Placebo comparator | Not described Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in faecal bacterial composition
Fluorescent in situ hybridisation
Measured: up to 28-day treatment period (six/participant in total)
Secondary outcomes (8)
Short chain fatty acid concentrations
Gas Chromatography
Measured: up to 28-day treatment period (six/participant in total)
Faecal water barrier function bioactivity
Trans-epithelial electrical resistance
Measured: up to 28-day treatment period (six/participant in total)
Bowel habits
Faecal diary
Measured: 7 days following each faecal sample provision (six diaries/participant in total)
Faecal characteristics
Faecal sample type by inspection (Bristol Stool Chart)
Measured: up to 28-day treatment period (six/participant in total)
Faecal output weight
Total faecal output weight
Measured: up to 28-day treatment period (six/participant in total)
Faecal pH
pH meter
Measured: up to 28-day treatment period (six/participant in total)
Food intake
Food diary analysed using a Food Composition Database
Measured: 4 days prior to each faecal sample provision (six diaries/participant in total)
Acute glycaemic response on subset of volunteers (n=20)
Oral glucose tolerance test following 1.Glucose + Alginate H1CC2012, or 2. Glucose
Measured: Two days (mornings) following crossover intervention study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startApr 2010
- Primary completionNov 2010
- Study completionDec 2010
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- CyberColloids Ltd., University of Reading, The Hebridean Seaweed Company, Marigot Ltd., Industrias Roko, S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608983
- Sponsor's protocol ID
- REC/09/003
- Acronym
- HYFFI
- Status last verified
- Nov 2015
- First submitted
- 8 Jul 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrocolloids as Functional Food Ingredients for Gut Health
- ClinicalTrials.gov ID
- NCT02608983
- Acronym / sponsor ID
- HYFFI / REC/09/003
- Conditions
- Healthy
- Keywords
- Seaweed, Hydrocolloid, Functional Food, Dietary Fibre, Prebiotic, Low molecular weight polysaccharides, Alginate, Agar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- CyberColloids Ltd., University of Reading, The Hebridean Seaweed Company, Marigot Ltd., Industrias Roko, S.A.
- Study start
- Apr 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Nov 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.
Seaweeds are a natural source of nutrients, and dependent on the variety, are rich in dietary fibre, proteins, essential vitamins and minerals. However this resource is highly underexploited. Countries such as Japan, China, North and South Korea are large consumers of edible seaweed while exposure in Western countries is much lower and mainly as industrially extracted seaweed derivatives, a common additive in many food and healthcare products. Seaweeds have been associated with a number of human gut promoting health benefits such as decreasing faecal transit time through the gastrointestinal tract thus preventing constipation and resulting in a reduced exposure to harmful substances (decreasing colon cancer risk). These health benefits can be attributed to seaweeds high dietary fibre content. Interestingly, the food and healthcare industry already utilize seaweed-extracted fibre in the manufacturing process thus steering the way forward towards the development of novel functional food products. These seaweed-extracted fibres are high molecular weight polysaccharides known as hydrocolloids and are non-digestible by humans, hence classified as dietary fibre.
Traditionally, seaweed derived polysaccharides (hydrocolloids) have been used to provide thickening and gelling functionality to food stuffs and other industrial applications however there is emerging evidence to show that lower molecular weight polysaccharides and oligosaccharides derived from these hydrocolloids can also act as a source of soluble fibre and may have prebiotic activity. Recent developments in Japan and Korea have lead to the commercial availability of products containing low molecular weight seaweed derived fibre. There is also some evidence for the beneficial effects of seaweed derived fibre in other key health areas such as cardiovascular health, cancer, diabetes and obesity. However, relatively little is known about the chemical, physio-chemical and fermentation characteristics of seaweed fibre in the human gut. Some hydrocolloids, notably guar gum (plant source), have also been employed for their health promoting properties in the areas of glucose tolerance and cholesterol lowering. However the use of hydrocolloids as functional food ingredients with health benefits for consumers has been rather limited and has focused more on uses in products for diabetics.
It is particularly in the area of gut health that small and medium-sized enterprises (SMEs) involved in hydrocolloid production and processing, can enter the functional food ingredients market by using innovative processing technology. The total dietary fibre content of seaweed can be as high as 75% of the total dry weight and a high proportion of this is soluble. The fibre component essentially comprises the structural polysaccharides i.e. alginate and fucoidan in brown seaweeds, carrageenan, agar and porphyran in red seaweeds and ulvan in green seaweeds. As these fibres are primarily soluble, they form viscous gels as they pass through the gastrointestinal tract. Some of the fibre is fermented in the lower intestine but in general, soluble and insoluble seaweed fibre tends to pass through the gut without being digested. In its natural form as part of the seaweed plant, this fibre is typically high in molecular weight and passes through the gut too rapidly for the gut microflora to utilize it to any great extent. There is therefore a necessity to develop lower molecular weight forms that are more soluble and can be added at higher concentrations to food products without affecting the sensory properties of the product.
The overall aim of the project is to realize an opportunity to produce low molecular weight polysaccharides (LMWP) from alginate- and agar-bearing seaweeds for applications in food \& health. The two effective agar and alginate LMWPs, identified by in vitro studies, will be selected for assessment of prebiotic activity in a feeding trial in human volunteers (Ulster University) as part of an European Union (EU) study. The end points to be assessed will be stimulation of beneficial bacteria (bifidogenic effects), increased short chain fatty acid production, beneficial effects on stool formation, and improvements in gut barrier function. Additionally, benefits of the LMWPs towards blood glucose levels (short term and acute) will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Dietary Supplement: Agar H1CC2013 |
| Treatment 2 | Experimental | Dietary Supplement: Agar H1CC2012 |
| Treatment 3 | Placebo comparator | Dietary Supplement: Maltodextrin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy individuals
- Age 18-55 years
- Non smoking
- BMI >20 and <35kg/m2
Key exclusion criteria (12 listed)
- Smoker
- Pregnant and lactating women
- Vegetarians and vegans
- Lactose intolerant individuals
- Diabetes
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 |
|---|---|---|
| Agar H1CC2013Following a 28-day washout one 250ml drink / day containing 8g of agar H1CC2013 as part of normal diet for 28 days | Dietary supplement | Treatment 1 |
| Agar H1CC2012Following a 28-day washout one 250ml drink / day containing 8g of agar H1CC2012 as part of normal diet for 28 days | Dietary supplement | Treatment 2 |
| MaltodextrinFollowing a 28-day washout one 250ml drink / day containing 8g of maltodextrin as part of normal diet for 28 days | Dietary supplement | Treatment 3 |
Primary outcome
Change in faecal bacterial composition
Time frame: up to 28-day treatment period (six/participant in total)
Fluorescent in situ hybridisation
8 secondary outcomes
Short chain fatty acid concentrations
Time frame: up to 28-day treatment period (six/participant in total)
Faecal water barrier function bioactivity
Time frame: up to 28-day treatment period (six/participant in total)
Bowel habits
Time frame: 7 days following each faecal sample provision (six diaries/participant in total)
Faecal characteristics
Time frame: up to 28-day treatment period (six/participant in total)
Faecal output weight
Time frame: up to 28-day treatment period (six/participant in total)
Faecal pH
Time frame: up to 28-day treatment period (six/participant in total)
Food intake
Time frame: 4 days prior to each faecal sample provision (six diaries/participant in total)
Acute glycaemic response on subset of volunteers (n=20)
Time frame: Two days (mornings) following crossover intervention study
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 20 Nov 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.
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 Agar H1CC2013, Agar H1CC2012 and Maltodextrin in people with Healthy, run by University of Ulster.
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 4 inclusion and 12 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 20 Nov 2015. 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. 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?
Change in faecal bacterial composition (time frame: up to 28-day treatment period (six/participant in total)). 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 20 Nov 2015.