NCT02608983

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

7 months

First QC Date

July 8, 2015

Last Update Submit

November 18, 2015

Conditions

Keywords

SeaweedHydrocolloidFunctional FoodDietary FibrePrebioticLow molecular weight polysaccharidesAlginateAgarHYFFILow molecular weight seaweed derived hydrocolloids as functional food ingredientssubjects

Outcome Measures

Primary Outcomes (1)

  • Change in faecal bacterial composition

    Fluorescent in situ hybridisation

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

Secondary Outcomes (8)

  • Short chain fatty acid concentrations

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

  • Faecal water barrier function bioactivity

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

  • Bowel habits

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

  • Faecal characteristics

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

  • Faecal output weight

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

  • +3 more secondary outcomes

Study Arms (3)

Treatment 1

EXPERIMENTAL
Dietary Supplement: Agar H1CC2013

Treatment 2

EXPERIMENTAL
Dietary Supplement: Agar H1CC2012

Treatment 3

PLACEBO COMPARATOR
Dietary Supplement: Maltodextrin

Interventions

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

Treatment 1
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

Treatment 2
MaltodextrinDIETARY_SUPPLEMENT

Following a 28-day washout one 250ml drink / day containing 8g of maltodextrin as part of normal diet for 28 days

Treatment 3

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals
  • Age 18-55 years
  • Non smoking
  • BMI \>20 and \<35kg/m2

You may not qualify if:

  • Smoker
  • Pregnant and lactating women
  • Vegetarians and vegans
  • Lactose intolerant individuals
  • Diabetes
  • Cardiovascular disease
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

maltodextrin

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2015

First Posted

November 20, 2015

Study Start

April 1, 2010

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

November 20, 2015

Record last verified: 2015-11