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)

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.

Study Overview

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

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Singapore, Singapore, 117599
        • Clinical Nutrition Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sumanto Haldar, PhD, Singapore Institute of Food and Biotechnology Innovation (SIFBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022/00909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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