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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 groups in NCT02608983
Study groupRoleWhat they receive
Treatment 1ExperimentalNot described
Receives: Dietary Supplement: Agar H1CC2013
Treatment 2ExperimentalNot described
Receives: Dietary Supplement: Agar H1CC2012
Treatment 3Placebo comparatorNot described
Receives: Dietary Supplement: Maltodextrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in faecal bacterial composition

    Fluorescent in situ hybridisation

    Measured: up to 28-day treatment period (six/participant in total)

Secondary outcomes (8)
  1. Short chain fatty acid concentrations

    Gas Chromatography

    Measured: up to 28-day treatment period (six/participant in total)

  2. Faecal water barrier function bioactivity

    Trans-epithelial electrical resistance

    Measured: up to 28-day treatment period (six/participant in total)

  3. Bowel habits

    Faecal diary

    Measured: 7 days following each faecal sample provision (six diaries/participant in total)

  4. Faecal characteristics

    Faecal sample type by inspection (Bristol Stool Chart)

    Measured: up to 28-day treatment period (six/participant in total)

  5. Faecal output weight

    Total faecal output weight

    Measured: up to 28-day treatment period (six/participant in total)

  6. Faecal pH

    pH meter

    Measured: up to 28-day treatment period (six/participant in total)

  7. Food intake

    Food diary analysed using a Food Composition Database

    Measured: 4 days prior to each faecal sample provision (six diaries/participant in total)

  8. 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.

  1. First posted20 Nov 2015 (estimated)
  2. Study startApr 2010
  3. Primary completionNov 2010
  4. Study completionDec 2010

Resources

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)
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

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.

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