- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05765448
Effects of the Consumption of SEAweed Biomass Versus PROtein Isolates on Postprandial Satiety and Metabolism (SEAPRO)
Effects of the Consumption of SEAweed Biomass Versus PROtein Isolates on Postprandial Satiety and Metabolism (The SEAPRO Study)
Study Overview
Status
Conditions
Intervention / Treatment
- Other: Soy control
- Other: Intervention (Laver/nori (Porphyra umbillicus) macroalgae whole biomass)
- Other: Intervention (Laver/nori macroalgae (Porphyra umbillicus) protein isolates)
- Other: Intervention (Chlorella microalgae (Chlorella vulgaris) whole biomass)
- Other: Intervention (Chlorella microalgae (Chlorella vulgaris) protein isolates)
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christiani Jeyakumar Henry, PhD
- Phone Number: 6407 0793
- Email: jeya_henry@sifbi.a-star.edu.sg
Study Locations
-
-
-
Singapore, Singapore, 117599
- Clinical Nutrition Research Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Soy-based control meal
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).
|
Soy isolate control meal
|
Experimental: Laver/nori macroalgae (Porphyra umbilicus) whole biomass-based treatment meal
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 (Porphyra umbillicus) macroalgae whole biomass treatment meal
|
Experimental: Laver/nori macroalgae (Porphyra umbilicus) protein isolates-based treatment meal
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).
|
Laver/nori macroalgae (Porphyra umbillicus) protein isolates treatment meal
|
Experimental: Microalgae (Chlorella vulgaris) whole biomass-based treatment meal
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).
|
Chlorella microalgae (Chlorella vulgaris) whole biomass treatment meal
|
Experimental: Microalgae (Chlorella vulgaris) protein isolates-based treatment meal
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).
|
Chlorella microalgae (Chlorella vulgaris) protein isolates treatment meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose
Time Frame: Up to 180 minutes
|
Serum glucose measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
|
Up to 180 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin
Time Frame: Up to 180 minutes
|
Serum insulin measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
|
Up to 180 minutes
|
Triglycerides
Time Frame: Up to 180 minutes
|
Serum triglycerides measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
|
Up to 180 minutes
|
Amino acids
Time Frame: Up to 180 minutes
|
Plasma amino acids measured at 0, 30, 60, 90, 120 and 180 minutes
|
Up to 180 minutes
|
GLP-1
Time Frame: Time Frame: Up to 180 minutes
|
Plasma GLP-1 measured at 0, 30, 60, 90, 120, 150 and 180 minutes
|
Time Frame: Up to 180 minutes
|
Ghrelin
Time Frame: Up to 180 minutes
|
Plasma ghrelin measured at 0, 30, 60, 90, 120, 150 and 180 minutes
|
Up to 180 minutes
|
Satiety
Time Frame: Up to 180 minutes
|
Satiety measured using VAS at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
|
Up to 180 minutes
|
Hunger
Time Frame: Up to 180 minutes
|
Hunger measured using VAS at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
|
Up to 180 minutes
|
Gastrointestinal symptoms
Time Frame: Up to 180 minutes
|
Gastrointestinal symptoms measured using gastrointestinal questionnaire at 0, 15, 60, 120 and 180 minutes
|
Up to 180 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sumanto Haldar, PhD, Singapore Institute of Food and Biotechnology Innovation (SIFBI)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022/00909
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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