Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000335594
Ethics application status
Approved
Date submitted
12/02/2024
Date registered
26/03/2024
Date last updated
4/08/2024
Date data sharing statement initially provided
26/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Seaweed meal protein bioavailability and acceptability in adults
Scientific title
The impact of a minimally processed seaweed meal on the appearance of amino acids in peripheral circulation in healthy adults
Secondary ID [1] 311482 0
Nil known
Universal Trial Number (UTN)
U1111-1298-5273
Trial acronym
SEAWEED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial protein appearance in circulation 332805 0
Micronutrient bioavailability 332806 0
Seaweed digestion 333044 0
Condition category
Condition code
Diet and Nutrition 329531 329531 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a seaweed meal (SWM; ~400 g), prepared from minimally processed seaweed to improve protein accessibility and optimise mineral content. The SWM is formulated as a dumpling meal containing 152 g dry weight of seaweed which provides approximately 3.1g protein from seaweed plus 8.4 g of protein from other non-seaweed ingredients. The non-seaweed ingredients are" potato starch, tapioca starch, soy, egg yolk, shiitake, soy sauce, wongbok cabbage, chikiang vinegar, spring onion, garlic, Panko (bread crumbs), shallots, spices, herbs, chili flakes, coriander, spring onion, salt, ginger. Participants will consume the meal under clinical monitoring on a single morning at the clinic within 10 minutes.
After a wash-out phase of minimum 3 days, the participants will cross over and receive the other treatment.
Intervention code [1] 327940 0
Treatment: Other
Comparator / control treatment
The comparator, a control meal (CON; ~250 g), will be a negative control. The CON is prepared under the same preparation method as the SWM, and its composition is identical to the SWM, but without the seaweed. Participants will consume the meal under clinical monitoring on a separate single morning at the clinic within 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 337333 0
The difference in plasma essential amino acid peak concentration (Cmax) between SWM and CON following acute ingestion in adults.
Timepoint [1] 337333 0
Before the intervention begins (at 0 min), and at 30, 60, 90, 120, 180, and 240 min post-ingestion at each visit.
Secondary outcome [1] 431479 0
The difference in individual amino acid appearance in peripheral circulation between SWM and CON.
Timepoint [1] 431479 0
Before the intervention begins (at 0 min), and at 30, 60, 90, 120, 180, 240 min post-ingestion at each visit.
Secondary outcome [2] 431482 0
The difference in K (potassium) in plasma/serum between SWM and CON.
Timepoint [2] 431482 0
Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post-ingestion at each visit.
Secondary outcome [3] 431483 0
The difference in heavy metal iAs in urine between SWM and CON.
Timepoint [3] 431483 0
Before the intervention begins (at 0 min), and post-ingestion up to 2 hours (0-120 min), between 2 to 4 hours (120-240 min) at each visit. A 24-hour urine sample (collected between 240 min and 24 hours the following day) will be collected at each visit.
Secondary outcome [4] 431489 0
The difference in subjective digestive comfort responses (patient-reported outcomes regarding comfort) between SWM and CON.
Timepoint [4] 431489 0
A visual analogue scale (VAS) completed by the participants upon arrival, immediately before and after study meal consumption, and 30, 60, 90, 120, 180, and 240 mins post-ingestion.
Secondary outcome [5] 431490 0
The difference in subjective appetite responses between SWM and CON.
Timepoint [5] 431490 0
Appetite scores will be completed by the participants upon arrival, immediately before and after study meal consumption, and 30, 60, 90, 120, 180, 240 mins post-ingestion at each visit.
Secondary outcome [6] 431494 0
The difference in metabolites of seaweed consumption in plasma between SWM and CON.
Timepoint [6] 431494 0
Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post-ingestion at each visit.
Secondary outcome [7] 431500 0
The difference in glucose responses between SWM and CON.
Timepoint [7] 431500 0
Before the intervention begins (at 0 min), and at 30, 60, 90, 120, 180, and 240 min post-ingestion at each visit.
Secondary outcome [8] 431503 0
The difference in postprandial triglycerides response between SWM and CON.
Timepoint [8] 431503 0
Before the intervention begins (at 0 min), and at 30, 60, 90, 120, 180, and 240 min post-ingestion at each visit.
Secondary outcome [9] 431590 0
The sensory evaluation (acceptability) responses between SWM and CON.
Timepoint [9] 431590 0
This will be completed by the participants after study meal consumption at each visit.
Secondary outcome [10] 432186 0
The difference in subjective digestive symptoms responses (patient-reported outcomes regarding symptoms) between SWM and CON.
Timepoint [10] 432186 0
A visual analogue scale (VAS) completed by the participants upon arrival, immediately before and after study meal consumption, and 30, 60, 90, 120, 180, and 240 mins post-ingestion.
Secondary outcome [11] 432187 0
The difference in insulin responses between SWM and CON.
Timepoint [11] 432187 0
Before the intervention begins (at 0 min), and at 30, 60, 90, 120, 180, and 240 min post-ingestion at each visit.
Secondary outcome [12] 432796 0
The difference in Na (sodium) in plasma/serum between SWM and CON.
Timepoint [12] 432796 0
Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post-ingestion at each visit.
Secondary outcome [13] 432797 0
The difference in Fe (iron) in plasma/serum between SWM and CON.
Timepoint [13] 432797 0
Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post-ingestion at each visit.
Secondary outcome [14] 432798 0
The difference in Mg (magnesium) in plasma/serum between SWM and CON.
Timepoint [14] 432798 0
Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post-ingestion at each visit.
Secondary outcome [15] 432799 0
The difference in Ca (calcium) in plasma/serum between SWM and CON.
Timepoint [15] 432799 0
Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post-ingestion at each visit.
Secondary outcome [16] 432800 0
The difference in I (iodine) in plasma/serum between SWM and CON.
Timepoint [16] 432800 0
Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post-ingestion at each visit.
Secondary outcome [17] 432801 0
The difference in untargeted minerals in plasma/serum between SWM and CON.
Timepoint [17] 432801 0
Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post-ingestion at each visit.
Secondary outcome [18] 432802 0
The difference in heavy metal total As in urine between SWM and CON.
Timepoint [18] 432802 0
Before the intervention begins (at 0 min), and post-ingestion up to 2 hours (0-120 min), between 2 to 4 hours (120-240 min) at each visit. A 24-hour urine sample (collected between 240 min and 24 hours the following day) will be collected at each visit.
Secondary outcome [19] 432803 0
The difference in heavy metal Cd in urine between SWM and CON.
Timepoint [19] 432803 0
Before the intervention begins (at 0 min), and post-ingestion up to 2 hours (0-120 min), between 2 to 4 hours (120-240 min) at each visit. A 24-hour urine sample (collected between 240 min and 24 hours the following day) will be collected at each visit.
Secondary outcome [20] 432804 0
The difference in heavy metal Pb in urine between SWM and CON.
Timepoint [20] 432804 0
Before the intervention begins (at 0 min), and post-ingestion up to 2 hours (0-120 min), between 2 to 4 hours (120-240 min) at each visit. A 24-hour urine sample (collected between 240 min and 24 hours the following day) will be collected at each visit.
Secondary outcome [21] 432805 0
The difference in heavy metal Hg in urine between SWM and CON.
Timepoint [21] 432805 0
Before the intervention begins (at 0 min), and post-ingestion up to 2 hours (0-120 min), between 2 to 4 hours (120-240 min) at each visit. A 24-hour urine sample (collected between 240 min and 24 hours the following day) will be collected at each visit.
Secondary outcome [22] 433296 0
The difference in K (potassium) in plasma/serum between SWM and CON.
Timepoint [22] 433296 0
Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post-ingestion at each visit.

Eligibility
Key inclusion criteria
a) Adult (18-60 years). Female participants must declare the stage of the menstrual cycle during the different study phases, if applicable.
b) A BMI between 18 and 30 kg/m2.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a) Inability to give informed consent
b) Known allergy to seaweed (Undaria or Ulva), or SWM or CON meal components, including potato starch, tapioca starch, soy, egg yolk, shiitake, soy sauce, wongbok cabbage, chikiang vinegar, spring onion, garlic, Panko (bread crumbs), shallots, spices, herbs, chili flakes, coriander, spring onion, salt, ginger.
c) Known medical conditions, chronic disease or current medication limiting iodine intake to below the upper level, including pregnancy, breastfeeding, thyroid conditions, such as hyperthyroidism, hypothyroidism, goiter, and/or thyroid autoimmunity.
d) Those who use supplemental iodine, other minerals, weight reducing pills, antioxidants, supplemental protein, etc. at the recruitment and those who stopped taking them within less than 1 month.
e) Those who are medically advised to restrict minerals or electrolytes.
f) Known significant gastrointestinal disorder (i.e., celiac, Inflammatory Bowel Disease, etc.)
g) Known chronic disease such as diabetes, cardiovascular, cancer, renal failure, previous gastrointestinal surgery other than cholecystectomy or appendectomy, neurological conditions such as multiple sclerosis, spinal cord injury, or stroke, self-reported alcohol intake exceeding a moderate intake (>28 units per week)
h) Current medication use expected to interfere with normal digestive or metabolic processes including proton pump inhibitors, laxatives, antibiotics etc.
i) Pregnancy, breastfeeding
j) Unwillingness to comply with the study procedures

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised to receive the SWM or the CON as the first in a crossover sequence using computer-generated sequences.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation sequence will be set up as though a web-based secure database. Sequences will be administered by the independent data management team and will not be accessible to the research team prior to allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
Statistical analyses will describe the relationship between the SWM and CON, as well as response changes following consumption (time).
This study intends to investigate the biological effects of both intervention and comparator, rather than efficacy. Therefore, study outcomes will be analysed on a per-protocol basis, including only those data that were obtained in adherence to the protocol.
Statistical analysis will be performed with SPSS (SPSS, IBM Corporation, Armonk, NY, USA) and R (R Development Core Team). Additional statistical programs appropriate for image, electronic data capture, or metabolomic analyses will be used as appropriate.
Although the statistical analysis could be modified based on the results, it is expected that the following statistical analysis will be conducted.
Interventions will be compared for the primary outcome using Student's paired t-test.
Categorical variables: Chi-squared tests (or Fisher’s Exact tests for small samples). Continuous variables will be applied to (parametric) t-tests or multi-factorial mixed models and (non-parametric) Mann-Whitney tests for symmetrically and asymmetrically distributed data, respectively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2024
Actual
28/03/2024
Date of last participant enrolment
Anticipated
31/12/2024
Actual
16/04/2024
Date of last data collection
Anticipated
10/01/2025
Actual
27/05/2024
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 26138 0
New Zealand
State/province [1] 26138 0
Auckland

Funding & Sponsors
Funding source category [1] 315768 0
Government body
Name [1] 315768 0
New Zealand Ministry of Business Innovation and Employment
Country [1] 315768 0
New Zealand
Primary sponsor type
Government body
Name
AgResearch
Address
Country
New Zealand
Secondary sponsor category [1] 317906 0
None
Name [1] 317906 0
Address [1] 317906 0
Country [1] 317906 0
Other collaborator category [1] 282952 0
University
Name [1] 282952 0
University of Auckland
Address [1] 282952 0
Country [1] 282952 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314628 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 314628 0
Ethics committee country [1] 314628 0
New Zealand
Date submitted for ethics approval [1] 314628 0
29/01/2024
Approval date [1] 314628 0
05/02/2024
Ethics approval number [1] 314628 0
2024 EXP 19377

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132214 0
Dr Farha Ramzan
Address 132214 0
Liggins Institute, University of Auckland, Private Bag 92019, Victoria Street West, Auckland 1142, New Zealand
Country 132214 0
New Zealand
Phone 132214 0
+6493737599
Fax 132214 0
Email 132214 0
[email protected]
Contact person for public queries
Name 132215 0
Farha Ramzan
Address 132215 0
Liggins Institute, University of Auckland, Private Bag 92019, Victoria Street West, Auckland 1142, New Zealand
Country 132215 0
New Zealand
Phone 132215 0
+6493737599
Fax 132215 0
Email 132215 0
[email protected]
Contact person for scientific queries
Name 132216 0
Farha Ramzan
Address 132216 0
Liggins Institute, University of Auckland, Private Bag 92019, Victoria Street West, Auckland 1142, New Zealand
Country 132216 0
New Zealand
Phone 132216 0
+6493737599
Fax 132216 0
Email 132216 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the Individual participant data collected during the interventions will be available after de-identification, along with the study protocol.
When will data be available (start and end dates)?
Data will be available beginning 3 months following the first publication of study results and ending 36 months following publication.
Available to whom?
Data will be available to investigators who provide a methodologically sound proposal approved by the Study Steering Committee, for use to achieve the aims in the approved proposal. Proposals should be directed to the principal investigator. To gain access, requests will need to sign a data access agreement.
Available for what types of analyses?
For use to achieve the aims in an approved proposal.
How or where can data be obtained?
Proposals should be directed to the principal investigator ([email protected]). To gain access, requests will need to sign a data access agreement.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.