NCT05765448

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

March 1, 2023

Last Update Submit

October 16, 2023

Conditions

Nutrition, Healthy

Keywords

alternative proteinpostprandial satiety

Outcome Measures

Primary Outcomes (1)

  • Glucose

    Serum glucose measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes

    Up to 180 minutes

Secondary Outcomes (8)

  • Insulin

    Up to 180 minutes

  • Triglycerides

    Up to 180 minutes

  • Amino acids

    Up to 180 minutes

  • GLP-1

    Time Frame: Up to 180 minutes

  • Ghrelin

    Up to 180 minutes

  • +3 more secondary outcomes

Study Arms (5)

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).

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).

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).

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).

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).

Other: Intervention (Chlorella microalgae (Chlorella vulgaris) protein isolates)

Interventions

Soy controlOTHER

Soy isolate control meal

Soy-based control meal
Intervention (Laver/nori (Porphyra umbillicus) macroalgae whole biomass)OTHER

Laver/nori (Porphyra umbillicus) macroalgae whole biomass treatment meal

Laver/nori macroalgae (Porphyra umbilicus) whole biomass-based treatment meal
Intervention (Laver/nori macroalgae (Porphyra umbillicus) protein isolates)OTHER

Laver/nori macroalgae (Porphyra umbillicus) protein isolates treatment meal

Laver/nori macroalgae (Porphyra umbilicus) protein isolates-based treatment meal
Intervention (Chlorella microalgae (Chlorella vulgaris) whole biomass)OTHER

Chlorella microalgae (Chlorella vulgaris) whole biomass treatment meal

Microalgae (Chlorella vulgaris) whole biomass-based treatment meal
Intervention (Chlorella microalgae (Chlorella vulgaris) protein isolates)OTHER

Chlorella microalgae (Chlorella vulgaris) protein isolates treatment meal

Microalgae (Chlorella vulgaris) protein isolates-based treatment meal

Eligibility Criteria

Age21 Years - 50 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Non-blinded, randomised crossover trial with each participant testing 5 different test ingredients on 5 separate study sessions on 5 days.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 13, 2023

Study Start

February 20, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)