Investigating the effect of a soluble seaweed dietary fibre on wellness, gut flora and metabolism.

In a population with a typical western diet and high BMI, does the addition of soluble seaweed dietary fibres to the diet change the overall gut function and microbiome structure?

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001057572

Acronym

BIOBELLY Biological Investigation Of Bowel Effects and Lowering Lipids for Your health from Seaweed

Enrollment

Registered

2015-10-12

Start date

2015-10-20

Completion date

2015-11-13

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We are undertaking one of the first seaweed dietary fibre and food ingredient studies on people with gut health concerns. The onset of chronic health disorders such as Type II Diabetes Mellitus are potentially related to reduced gut health. If seaweed dietary fibres can help improve the gut condition then it may be one option for preventing diabetic and other growing health concerns related to the gut. Previous research in other laboratory studies and in animal trials with seaweed dietary fibres, have shown significant reductions in inflammation, glucose & insulin stress, as well as positive shifts in gut flora composition. Despite the well-established evidence for the safety of consumption of the identified seaweeds and their dietary fibre extracts, very few studies have investigated the health outcomes in human trials. We will test if an Australian species seaweed, dietary-fibre extract and food ingredient can help the gut health condition, as well as assess changes to blood health indices and quality of life.

Interventions

This is a first human pilot study for the intervention of soluble dietary fibre from seaweed. Participants will be recruited and randomly assigned to a 4g, 2g or placebo control group for soluble extract from seaweed. This is to be ingested daily for 6 weeks and blood, urine and faeces samples will be tested before and after the intervention. Participants are provided a magnetic fridge tick list to record daily adherence and will return supplement containers that had been stocked with recorded r

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Overweight (BMI>24) individuals consuming an average western diet (as identified by K:Na ratio in 24hr urine and the initial record of 3 random 24hr dietary intakes). Presence of mild gut health concerns are allowed but not a requirement.

Exclusion criteria

BMI<24 Concerning indications of very high blood pressure (as measured during recruitment or self diagnosed) Very high glucose sensitivity Medication of antibiotics (participants may finish with a shorter intervention if antibiotics are required) Any other severe digestive conditions such as IBS or Chrons disease. Coronary Heart Disease

Outcome results