Alternative ProtEin Satiety Study (APES Study) (APES)

September 30, 2024 updated by: Teo Pey Sze, Singapore Institute of Food and Biotechnology Innovation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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
  • 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:

  • 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 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

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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
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
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.
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
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.
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
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.
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
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.
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Singapore Institute of Food and Biotechnology Innovation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pey Sze Teo, 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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-089

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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