Nutrition, HealthySEAPRONCT05765448
Effects of the Consumption of SEAweed Biomass Versus PROtein Isolates on Postprandial Satiety and Metabolism
A study testing Intervention (Laver/nori (Porphyra umbillicus) macroalgae whole biomass), Intervention (Laver/nori macroalgae (Porphyra umbillicus) protein isolates) and Intervention (Chlorella microalgae (Chlorella vulgaris) whole biomass) in people with Nutrition, Healthy, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
There is a need to identify alternative sources of protein that can be introduced into diets to effectively meet the protein requirements of the population. Seaweed presents a potential source of sustainable, alternative protein. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Intervention (Laver/nori (Porphyra umbillicus) macroalgae whole biomass), Intervention (Laver/nori macroalgae (Porphyra umbillicus) protein isolates) and Intervention (Chlorella microalgae (Chlorella vulgaris) whole biomass)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Feb 2023to Jun 2024
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Chinese ethnicity
- Aged 21 to 50 years
- Able to give informed consent
- Body Mass Index (BMI) of 18.5 to 25.0 kg/m2
Who cannot join
- Diabetic (HbA1C ≥ 6.5%)
- Smoking
- Having a dislike towards seaweed- or soy-based products
- Having allergies or intolerances to any common food ingredients including seaweed, soy, eggs, seafood, fish, milk, peanuts, tree nuts, wheat, gluten, cereal, fruits, dairy products, meat, vegetables, sugar, sweeteners, natural food colourings or flavourings, etc.
- Following special diets or having intentional dietary restrictions (e.g, vegetarians/vegans)
- Not willing to adhere to diet modification as in the study protocol
Show all 17Show fewer
- Taking part in strenuous physical activities
- Not willing to stop any strenuous activity during or within 24 hours of study days (for those actively participating in sports at the competitive and/or endurance levels)
- Having glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Having alcohol consumption on > 4 days per week with ≥ 6 alcoholic drinks per week
- Having sustained elevation of blood pressure (≥140/90 mm Hg)
- Having previously undergone any gastrointestinal surgery or having history of gastrointestinal disorders
- Having a history of heart, liver, kidney, blood disorders (e.g., thalassemia) or thyroid dysfunctions
- Having history of tuberculosis, HIV, Hepatitis B or Hepatitis C infections
- Having any prescription medication or any other alternative medicines or supplements which may interfere with study measurements in the opinion of the study investigators
- Having donated blood within 4 weeks of study participation
- Having poor veins or having history of severe vasovagal syncope (blackouts or fainting) from blood draws
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Consumption of SEAweed Biomass Versus PROtein Isolates on Postprandial Satiety and Metabolism (The SEAPRO Study)
There is a need to identify alternative sources of protein that can be introduced into diets to effectively meet the protein requirements of the population. Seaweed presents a potential source of sustainable, alternative protein. In order to determine their utility in future foods, in this study we will undertake an acute postprandial trial to explore whether a macroalgae (porphyra) and a microalgae (chlorella) protein isolates are more beneficial for acute metabolic health as compared to their respective whole biomasses. In particular, we will compare the effects of whole biomasses and their protein isolates on acute glucose homeostasis, amino acid availability as well as on satiety and gut hormones.
Read the detailed description
Seaweed presents a potential source of sustainable, alternative protein. Broadly categorised into macroalgae and microalgae, macroalgae including those of the genus Porphyra are traditionally known as nori or laver and is a common ingredient in several Asian dishes such as soups and sushi. Porphyra is rich in protein, micronutrients and dietary fibre and the equivalent variety in New Zealand is a red macroalgae known as Karengo. A prominent genus of microalgae is Chlorella, which is a green microalgae also rich in protein and currently used mainly in dietary supplements. The interest in seaweed as an ingredient incorporated into meals, food products and dietary supplements has been growing due to their macronutrient composition and bioactive substances with studied health benefits including improvements in glucose homeostasis, appetite and anti-hypertensive and hypocholesterolemic properties.
However, controlled human studies comparing specific macroalgae and microalgae, particularly for their potential to be used as a source of alternative protein, has been limited. Therefore, the present study aims to compare macroalgae (Porphyra) biomass and its protein isolates versus microalgae (Chlorella) biomass and its protein isolates on postprandial satiety and nutrient metabolism in healthy adult Chinese males by adding these as ingredients to a noodle soup dish. We specifically aim to explore whether the protein isolates are superior to the respective whole biomasses in terms of glucose homeostasis, amino acid availability as well as in terms of satiety and gut hormones. Results from this study will be used towards future food applications to enhance the potential of the use of seaweed as a sustainable and nutritious source of alternative proteins.
- Conditions
- Nutrition, Healthy
- Being tested
- Soy control, Intervention (Laver/nori (Porphyra umbillicus) macroalgae whole biomass), Intervention (Laver/nori macroalgae (Porphyra umbillicus) protein isolates), Intervention (Chlorella microalgae (Chlorella vulgaris) whole biomass), Intervention (Chlorella microalgae (Chlorella vulgaris) protein isolates)
- Keywords
- alternative protein, postprandial satiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy controlOther
Soy isolate control meal
Intervention (Laver/nori (Porphyra umbillicus) macroalgae whole biomass)Other
Laver/nori (Porphyra umbillicus) macroalgae whole biomass treatment meal
Intervention (Laver/nori macroalgae (Porphyra umbillicus) protein isolates)Other
Laver/nori macroalgae (Porphyra umbillicus) protein isolates treatment meal
Intervention (Chlorella microalgae (Chlorella vulgaris) whole biomass)Other
Chlorella microalgae (Chlorella vulgaris) whole biomass treatment meal
Intervention (Chlorella microalgae (Chlorella vulgaris) protein isolates)Other
Chlorella microalgae (Chlorella vulgaris) protein isolates treatment meal
| Study group | Role | What they receive |
|---|---|---|
| Soy-based control meal | Active comparator | Bowl of soup noodles prepared with 10g soy protein isolate soup base and consumed with a pack of plain crackers (approximately 65g available carbohydrate in total). Receives: Other: Soy control |
| Laver/nori macroalgae (Porphyra umbilicus) whole biomass-based treatment meal | Experimental | Bowl of soup noodles prepared with 10g Laver/nori macroalgae (Porphyra umbilicus) whole biomass soup base and consumed with a pack of plain crackers (approximately 65g available carbohydrate in total). Receives: Other: Intervention (Laver/nori (Porphyra umbillicus) macroalgae whole biomass) |
| Laver/nori macroalgae (Porphyra umbilicus) protein isolates-based treatment meal | Experimental | Bowl of soup noodles prepared with 10g Laver/nori macroalgae (Porphyra umbilicus) protein isolates soup base and consumed with a pack of plain crackers (approximately 65g available carbohydrate in total). Receives: Other: Intervention (Laver/nori macroalgae (Porphyra umbillicus) protein isolates) |
| Microalgae (Chlorella vulgaris) whole biomass-based treatment meal | Experimental | Bowl of soup noodles prepared with 10g microalgae (Chlorella vulgaris) whole biomass soup base and consumed with a pack of plain crackers (approximately 65g available carbohydrate in total). Receives: Other: Intervention (Chlorella microalgae (Chlorella vulgaris) whole biomass) |
| Microalgae (Chlorella vulgaris) protein isolates-based treatment meal | Experimental | Bowl of soup noodles prepared with 10g microalgae (Chlorella vulgaris) protein isolates soup base and consumed with a pack of plain crackers (approximately 65g available carbohydrate in total). Receives: Other: Intervention (Chlorella microalgae (Chlorella vulgaris) protein isolates) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Serum glucose measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Measured: Up to 180 minutes
Secondary outcomes (8)
Insulin
Serum insulin measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Measured: Up to 180 minutes
Triglycerides
Serum triglycerides measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Measured: Up to 180 minutes
Amino acids
Plasma amino acids measured at 0, 30, 60, 90, 120 and 180 minutes
Measured: Up to 180 minutes
GLP-1
Plasma GLP-1 measured at 0, 30, 60, 90, 120, 150 and 180 minutes
Measured: Time Frame: Up to 180 minutes
Ghrelin
Plasma ghrelin measured at 0, 30, 60, 90, 120, 150 and 180 minutes
Measured: Up to 180 minutes
Satiety
Satiety measured using VAS at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Measured: Up to 180 minutes
Hunger
Hunger measured using VAS at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Measured: Up to 180 minutes
Gastrointestinal symptoms
Gastrointestinal symptoms measured using gastrointestinal questionnaire at 0, 15, 60, 120 and 180 minutes
Measured: Up to 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start20 Feb 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Non-blinded, randomised crossover trial with each participant testing 5 different test ingredients on 5 separate study sessions on 5 days.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765448
- Sponsor's protocol ID
- 2022/00909
- Acronym
- SEAPRO
- Status last verified
- Oct 2023
- First submitted
- 1 Mar 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Consumption of SEAweed Biomass Versus PROtein Isolates on Postprandial Satiety and Metabolism (The SEAPRO Study)
- ClinicalTrials.gov ID
- NCT05765448
- Acronym / sponsor ID
- SEAPRO / 2022/00909
- Conditions
- Nutrition, Healthy
- Keywords
- alternative protein, postprandial satiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a need to identify alternative sources of protein that can be introduced into diets to effectively meet the protein requirements of the population. Seaweed presents a potential source of sustainable, alternative protein. In order to determine their utility in future foods, in this study we will undertake an acute postprandial trial to explore whether a macroalgae (porphyra) and a microalgae (chlorella) protein isolates are more beneficial for acute metabolic health as compared to their respective whole biomasses. In particular, we will compare the effects of whole biomasses and their protein isolates on acute glucose homeostasis, amino acid availability as well as on satiety and gut hormones.
Detailed description
Seaweed presents a potential source of sustainable, alternative protein. Broadly categorised into macroalgae and microalgae, macroalgae including those of the genus Porphyra are traditionally known as nori or laver and is a common ingredient in several Asian dishes such as soups and sushi. Porphyra is rich in protein, micronutrients and dietary fibre and the equivalent variety in New Zealand is a red macroalgae known as Karengo. A prominent genus of microalgae is Chlorella, which is a green microalgae also rich in protein and currently used mainly in dietary supplements. The interest in seaweed as an ingredient incorporated into meals, food products and dietary supplements has been growing due to their macronutrient composition and bioactive substances with studied health benefits including improvements in glucose homeostasis, appetite and anti-hypertensive and hypocholesterolemic properties.
However, controlled human studies comparing specific macroalgae and microalgae, particularly for their potential to be used as a source of alternative protein, has been limited. Therefore, the present study aims to compare macroalgae (Porphyra) biomass and its protein isolates versus microalgae (Chlorella) biomass and its protein isolates on postprandial satiety and nutrient metabolism in healthy adult Chinese males by adding these as ingredients to a noodle soup dish. We specifically aim to explore whether the protein isolates are superior to the respective whole biomasses in terms of glucose homeostasis, amino acid availability as well as in terms of satiety and gut hormones. Results from this study will be used towards future food applications to enhance the potential of the use of seaweed as a sustainable and nutritious source of alternative proteins.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Non-blinded, randomised crossover trial with each participant testing 5 different test ingredients on 5 separate study sessions on 5 days.
| Arm | Type | Receives |
|---|---|---|
| Soy-based control meal | Active comparator | Other: Soy controlBowl of soup noodles prepared with 10g soy protein isolate soup base and consumed with a pack of plain crackers (approximately 65g available carbohydrate in total). |
| Laver/nori macroalgae (Porphyra umbilicus) whole biomass-based treatment meal | Experimental | Other: Intervention (Laver/nori (Porphyra umbillicus) macroalgae whole biomass)Bowl of soup noodles prepared with 10g Laver/nori macroalgae (Porphyra umbilicus) whole biomass soup base and consumed with a pack of plain crackers (approximately 65g available carbohydrate in total). |
| Laver/nori macroalgae (Porphyra umbilicus) protein isolates-based treatment meal | Experimental | Other: Intervention (Laver/nori macroalgae (Porphyra umbillicus) protein isolates)Bowl of soup noodles prepared with 10g Laver/nori macroalgae (Porphyra umbilicus) protein isolates soup base and consumed with a pack of plain crackers (approximately 65g available carbohydrate in total). |
| Microalgae (Chlorella vulgaris) whole biomass-based treatment meal | Experimental | Other: Intervention (Chlorella microalgae (Chlorella vulgaris) whole biomass)Bowl of soup noodles prepared with 10g microalgae (Chlorella vulgaris) whole biomass soup base and consumed with a pack of plain crackers (approximately 65g available carbohydrate in total). |
| Microalgae (Chlorella vulgaris) protein isolates-based treatment meal | Experimental | Other: Intervention (Chlorella microalgae (Chlorella vulgaris) protein isolates)Bowl of soup noodles prepared with 10g microalgae (Chlorella vulgaris) protein isolates soup base and consumed with a pack of plain crackers (approximately 65g available carbohydrate in total). |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- Chinese ethnicity
- Aged 21 to 50 years
- Able to give informed consent
- Body Mass Index (BMI) of 18.5 to 25.0 kg/m2
Key exclusion criteria (17 listed)
- Diabetic (HbA1C ≥ 6.5%)
- Smoking
- Having a dislike towards seaweed- or soy-based products
- Having allergies or intolerances to any common food ingredients including seaweed, soy, eggs, seafood, fish, milk, peanuts, tree nuts, wheat, gluten, cereal, fruits, dairy products, meat, vegetables, sugar, sweeteners, natural food colourings or flavourings, etc.
- Following special diets or having intentional dietary restrictions (e.g, vegetarians/vegans)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy controlSoy isolate control meal | Other | Soy-based control meal |
| Intervention (Laver/nori (Porphyra umbillicus) macroalgae whole biomass)Laver/nori (Porphyra umbillicus) macroalgae whole biomass treatment meal | Other | Laver/nori macroalgae (Porphyra umbilicus) whole biomass-based treatment meal |
| Intervention (Laver/nori macroalgae (Porphyra umbillicus) protein isolates)Laver/nori macroalgae (Porphyra umbillicus) protein isolates treatment meal | Other | Laver/nori macroalgae (Porphyra umbilicus) protein isolates-based treatment meal |
| Intervention (Chlorella microalgae (Chlorella vulgaris) whole biomass)Chlorella microalgae (Chlorella vulgaris) whole biomass treatment meal | Other | Microalgae (Chlorella vulgaris) whole biomass-based treatment meal |
| Intervention (Chlorella microalgae (Chlorella vulgaris) protein isolates)Chlorella microalgae (Chlorella vulgaris) protein isolates treatment meal | Other | Microalgae (Chlorella vulgaris) protein isolates-based treatment meal |
Primary outcome
Glucose
Time frame: Up to 180 minutes
Serum glucose measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
8 secondary outcomes
Insulin
Time frame: Up to 180 minutes
Triglycerides
Time frame: Up to 180 minutes
Amino acids
Time frame: Up to 180 minutes
GLP-1
Time frame: Time Frame: Up to 180 minutes
Ghrelin
Time frame: Up to 180 minutes
Satiety
Time frame: Up to 180 minutes
Hunger
Time frame: Up to 180 minutes
Gastrointestinal symptoms
Time frame: Up to 180 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention (Laver/nori (Porphyra umbillicus) macroalgae whole biomass), Intervention (Laver/nori macroalgae (Porphyra umbillicus) protein isolates) and Intervention (Chlorella microalgae (Chlorella vulgaris) whole biomass) in people with Nutrition, Healthy, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
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 5 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Glucose (time frame: Up to 180 minutes). 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 18 Oct 2023.