Healthy Male Adults ParticipantsAPESNCT06623812
Alternative ProtEin Satiety Study (APES Study)
A study testing Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake in people with Healthy Male Adults Participants, run by Singapore Institute of Food and Biotechnology Innovation.
Trial 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. 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
- Healthy Male Adults Participants
- What is being tested?
- Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 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
- Healthy male
- Aged between 21 and 50-year-old
- Are of normal weight (BMI 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
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- 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
Who cannot join
- 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
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- 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 Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Satiety Responses of Meals Consisting of Different Protein Sources
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.
- Conditions
- Healthy Male Adults Participants
- Being tested
- Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake
- Keywords
- Satiety, Alternative Protein, Protein Quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intakeOther
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
| Study group | Role | What they receive |
|---|---|---|
| Animal Protein | Active comparator | 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. Receives: Other: Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake |
| Plant Protein 1 with lower DIAAS Score (lower protein quality) | Active comparator | 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. Receives: Other: Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake |
| Plant Protein 2 with higher DIAAS Score (higher protein quality) | Active comparator | 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. Receives: Other: Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male Adults ParticipantsStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Teo Pey Sze, Singapore Institute of Food and Biotechnology Innovation
- Investigators
- Pey Sze Teo, PhD, Principal investigator, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623812
- Sponsor's protocol ID
- 2024-089
- Acronym
- APES
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 2 Oct 2024
- 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 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satiety Responses of Meals Consisting of Different Protein Sources
- ClinicalTrials.gov ID
- NCT06623812
- Acronym / sponsor ID
- APES / 2024-089
- Conditions
- Healthy Male Adults Participants
- Keywords
- Satiety, Alternative Protein, Protein Quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Oct 2024 (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.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Animal Protein | Active comparator | Other: Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intakeA 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. |
| Plant Protein 1 with lower DIAAS Score (lower protein quality) | Active comparator | Other: Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intakeA 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. |
| Plant Protein 2 with higher DIAAS Score (higher protein quality) | Active comparator | Other: Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intakeA 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. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male
- Aged between 21 and 50-year-old
- Are of normal weight (BMI 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
Key exclusion criteria (13 listed)
- 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.)
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 |
|---|---|---|
| Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intakeInvestigate 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 | Other | Animal Protein, Plant Protein 1 with lower DIAAS Score (lower protein quality), Plant Protein 2 with higher DIAAS Score (higher protein quality) |
Primary outcome
Post-Prandial Sensor Glucose Readings
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
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.
Oral processing behaviour
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
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
Change in Post breakfast satiety responses
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
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.
Ad-libitum snack intake
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
Participants will be asked to eat an ad-libitum amount of snack 2h post lunch. The amount of food consumed will be weighed.
Subsequent food intake post test meal
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
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.
Change in Post lunch satiety responses
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- 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.
Pey Sze Teo, PhD principal investigator
Singapore Institute of Food and Biotechnology Innovation
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Post- meal satiety and subsequent ad-libitum meal energy intake in people with Healthy Male Adults Participants, run by Singapore Institute of Food and Biotechnology Innovation.
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 10 inclusion and 13 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 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Pey Sze Teo, PhD (+65 64070497, Teo_Pey_Sze@sifbi.a-star.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Prandial Sensor Glucose Readings (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). The study lists 6 primary outcomes in all. 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 2 Oct 2024.