The Effects of Fermented Brown Seaweed Intake on Glucose Metabolism and Gut Health

NCT06418763 | Active Not Recruiting

• 1 other identifier: SEAPRO01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomised, controlled, cross-over study is to investigate whether the intake of fermented brown seaweed can lower postprandial blood glucose levels and influence the composition of the gut microbiota in 25 healthy volunteers. Well-being and gastrointestinal symptoms as well as sensory properties of the products will also be evaluated using questionnaires. At the screening visit, the subjects will be informed about the study procedures and inclusion/exclusion criteria will be checked. Informed consent will be signed by each subject before participating in the study. The participants will consume the active and control product, respectively, for 5 days with a 14-day wash-out period in between. Capillary blood samples will be drawn for glucose measurement at the first day of each 5-day intervention period. Faecal samples will be collected before and after each 5-day intervention period to analyse changes in gut microbial composition.

Conditions

Healthy Subjects

Keywords

seaweed; blood glucose; gut microbiota

Outcome Measures

Primary Outcomes (1)

• Postprandial blood glucose

  iAUC 0- 180 minutes

  0- 180 minutes (after intake of the study product)

Secondary Outcomes (1)

• Gut microbiota

  Before and immediately after each 5-day intake period

Study Arms (2)

Baobab spread mixed with fermented seaweed

ACTIVE COMPARATOR

Daily intake 2x 15g The product is available as a spread and will be consumed with bread

Dietary Supplement: Baobab spread mixed with fermented brown seaweed

Baobab spread

PLACEBO COMPARATOR

Daily intake 2x 15g The product is available as a spread and will be consumed with bread

Dietary Supplement: Baobab spread

Interventions

Baobab spread mixed with fermented brown seaweed DIETARY_SUPPLEMENT

5-day intake period

Baobab spread mixed with fermented seaweed

Baobab spread DIETARY_SUPPLEMENT

5-day intake period

Baobab spread

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females
• Age 20-40 years, at the time of signing the informed consent
• BMI 20-25 kg/m2
• Stable body weight (less than 5% difference during the last 3 months)
• Willing and able to give written informed consent for participating the study
• Willing to comply with all study procedures

You may not qualify if:

• Intake of antibiotics within 4 weeks prior to the start of the study
• Regular intake of probiotics and/or prebiotics within 4 weeks prior to the start of the study
• Tobacco use (smoking and/or snus)
• High alcohol intake: \> 4 glasses daily
• Pregnancy or lactating
• Chronical disease (e.g., liver, kidney)
• Diabetes
• Gastrointestinal disease (ulcerative colitis, Crohn's disease, irritable bowel syndrome)
• Heart disease (within the last 12 months)
• Inflammatory disease (e.g. asthma, GI inflammatory diseases) and auto-immune disease
• Treatment with corticosteroids of significant degree
• Psychological disease of significant degree
• Cancer of significant difference
• Gastric-bypass operation
• Operation planned during the study period

Sponsors & Collaborators

• Aventure AB: lead
• Lund University: collaborator
• Carbiotix AB: collaborator

Study Sites (1)

Aventure Clinical Trial Unit

Lund, Sweden

Location

Study Officials

• Lieselotte Cloetens

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 17, 2024
• Study Start: April 22, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)