ClinicalTrials.gg
Not yet recruitingNCT06623812APESUpdated Oct 2, 2024

Alternative ProtEin Satiety Study (APES Study)

An interventional study of Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake in Healthy Male Adults Participants, sponsored by Singapore Institute of Food and Biotechnology Innovation. Not yet recruiting. Open to male participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-02.

Sponsored by Singapore Institute of Food and Biotechnology Innovation · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
Male
01

Study summary

This project aims to study the effects of different protein quality (i.e. high vs. low) and protein sources (i.e. plant protein vs. conventional animal protein) on post-meal satiety and satisfaction. The protein quality score of meals will be calculated using the published digestible indispensable amino acid score (DIAAS). The proposed study will investigate the link between protein quality, protein source, and the post-meal satiety responses, using a realistic lunch meal approach, in humans. Other than the self-reported visual analogue scale (VAS) satiety response, the postprandial glucose dips (i.e. 2-3hours post-meal) will be collected by continuous glucose monitoring (CGMS) as an objective indicator of postprandial self-reported hunger and subsequent energy intake. In addition, the oral processing behaviours of participants will be captured and compared between the test meals.

Read the detailed description

Aim: To investigate how differences in protein quality (i.e. high vs low quality) and protein sources (i.e. plant vs animal proteins) influence the satisfaction, satiety responses (fullness over the time) and subsequent food intake.

02

Conditions studied

  • Healthy Male Adults Participants

Keywords

  • Satiety
  • Alternative Protein
  • Protein Quality
03

In context

Lead sponsor

Singapore Institute of Food and Biotechnology Innovation is the lead sponsor of 69 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy male
  • Aged between 21 and 50-year-old
  • Are of normal weight ( 18-25kg/m2)
  • Stable weight for the previous 12 months (\<5kg weight fluctuation in the previous year)
  • Healthy dentition and ability to bite, chew and swallow normally
  • No history of pain or discomfort in jaw movements or excessive teeth clenching or grinding
  • No dental carries or periodontal disease
  • Own a mobile device with Apple iOS Operating System version 15.0 -17.3 or Android Operating System version 10-14
  • Have access to a data plan
  • Comfortable with needles and insertion of a Continuous Glucose Monitoring System device for 3-7 days

Exclusion criteria

Exclusion Criteria:

  • Are a smoker
  • Have any dislikes, intolerances or allergies to foods or common food ingredients e.g. nuts, soya, wheat, gluten, cereal, fruits, biscuits, dairy products, rice, vegetable, meat, seafood, sugar and sweetener, gelatin, natural food colourings or flavourings (e.g. MSG), etc.
  • Have any specific dietary requirements and/ or restrictions (e.g. Vegan/ vegetarian, religious beliefs, lactose intolerance, calorie restricted diet etc.)
  • Known sensitivity to medical-grade adhesives
  • Bleeding disorders (e.g Hemophilia, von Willebrand disease etc.)
  • Have sinus problems that affect your taste and smell
  • Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Are taking insulin or medication known to affect your appetite or metabolism
  • Have major chronic diseases such as heart disease, cancer or diabetes mellitus etc.
  • Have active Tuberculosis (TB) or currently receiving treatment for TB
  • Have any known Chronic Infection or known to suffer from or have previously suffered from or is a carrier of Virus (HBV), Virus (HCV), (HIV)
  • Are a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
  • Are enrolled in a concurrent research study judged not to be scientifically or medically compatible with this study
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Animal Protein

    A standardized typical lunch test meal consists of an animal-based protein source (Animal Protein). The total weight of meal, total energy served, as well as energy from macronutrients are standardized across the three test meals.

    Other: Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake

  • Active comparator
    Plant Protein 1 with lower DIAAS Score (lower protein quality)

    A standardized typical lunch test meal consists of a plant-based protein source with a lower DIAAS Score (Plant protein 1- lower protein quality). The total weight of meal, total energy served, as well as energy from macronutrients are standardized across the three test meals.

    Other: Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake

  • Active comparator
    Plant Protein 2 with higher DIAAS Score (higher protein quality)

    A standardized typical lunch test meal consists of a plant-based protein source with a higher DIAAS Score (Plant protein 2- higher protein quality). The total weight of meal, total energy served, as well as energy from macronutrients are standardized across the three test meals.

    Other: Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake

Interventions

  • OtherBehavioral: Post- meal satiety and subsequent ad-libitum meal energy intake

    Investigate differences in post meal satiety and subsequent post meal energy intake after consuming fixed portion meals with different protein source and/ or different protein quality

06

What researchers measure

Primary outcomes

  1. Post-Prandial Sensor Glucose Readings

    A continuous monitoring glucose sensor will be used to measure participants sensor glucose readings. The post-prandial sensor glucose readings 2-3h post meal will be used as an objective indicator of postprandial self-reported hunger and subsequent energy intake.

    Time frame: During the test day 2, 5, 8, up to 48 hours per test day. There is a one-week wash-out period between test days

  2. Oral processing behaviour

    Participants will be video recorded during the lunch sessions to measure oral processing behavior (e.g., derived from number of bites, chews, swallows and eating duration) of the fixed portion test meals using an annotation software

    Time frame: During test day 2, 5 and 8, up to 20 minutes per test day. There is a one-week wash-out period between test days

  3. Change in Post breakfast satiety responses

    Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at: Not at all (0) to Extremely (100), where a higher score will indicate greater intensity.

    Time frame: During test day 2, 5 and 8, at 15- or 30-minutes intervals, up to 4 hours each test day. There is a one-week wash-out period between test days

  4. Ad-libitum snack intake

    Participants will be asked to eat an ad-libitum amount of snack 2h post lunch. The amount of food consumed will be weighed.

    Time frame: During test day 2, 5, and 8, up to 15 minutes per test day. There is a one-week wash-out period between test days

  5. Subsequent food intake post test meal

    Participants will be asked to bring a food dairy home to record their food and beverage intake for the rest of the test day. This is to assess participants calorie intake for the remaining day on the test session.

    Time frame: During test day 2, 5 and 8, up to participant's bedtime per test day (before 12am midnight of the next day). There is a one-week wash-out period between test days

  6. Change in Post lunch satiety responses

    Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at: Not at all (0) to Extremely(100), where a higher score will indicate greater intensity.

    Time frame: During test day 2, 5 and 8, at 15- or 30-minutes intervals, up to 2 hours each test day. There is a one-week wash-out period between test days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2024; primary completion for Dec 2024, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2024
First posted
Oct 2, 2024
StartEst.
Oct 2024
Primary completionEst.
Dec 2024
CompletionEst.
Dec 2024
Last update
Oct 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06623812
Lead sponsor
Singapore Institute of Food and Biotechnology Innovation
Responsible party
Teo Pey Sze (Senior Scientist I, Singapore Institute of Food and Biotechnology Innovation) — Principal investigator
First posted
Oct 2, 2024
Start date
Oct 2024 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Oct 2, 2024

Study contacts

Pey Sze Teo, PhD
Contact
Teo_Pey_Sze@sifbi.a-star.edu.sg
+65 64070497
Amanda Lim, BSc
Contact
amanda_lim@sifbi.a-star.edu.sg
64070423
Pey Sze Teo, PhD
principal investigator · Singapore Institute of Food and Biotechnology Innovation (SIFBI)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion