Singapore Healthy Alternative Protein Evaluation Study (SHAPES)

July 4, 2022 updated by: JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore
The overall aim of this randomized controlled trial is to investigate the effects of consuming a Plant-Based Meat alternative Diet (PBMD) compared to an Animal-Based Meat Diet (ABMD) on cardiometabolic health and protein homeostasis in Chinese men and women in Singapore. This will be achieved through the following specific objectives: (1) To evaluate the effects of dietary protein source on metabolic health and glycemic control(2) To evaluate the effects of dietary protein source on risk factors of cardiovascular diseases (3) To evaluate the effects of dietary protein source on protein homeostasis and metabolism.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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 (Anticipated)

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.
100

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 Locations

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

26 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Chinese males and females
  2. Age > 30 to </= 70 years
  3. Habitually consuming between 2 and 4 servings of protein-rich foods daily (~20 g protein per serving)
  4. Raised blood glucose (fasting glucose >/= 5.4 and </= 7.0 mmol/L) and/or (HbA1c >/= 5.7 and </= 6.4 %)
  5. Fully vaccinated against COVID-19 (referred to as having completed a minimum of 2 doses Pfizer-BioNTech / Comirnaty / Moderna or 3 doses Sinovac-CoronaVac)
  6. Ability to give an informed consent
  7. Willing to adhere to study intervention procedures

Exclusion Criteria:

  1. Obese: BMI (>/= 27.5 kg/m2) and/or waist circumference (>/= 102 cm for male; >/= 88 cm for female)
  2. Significant weight change (± 5 % body weight) during the past 3 months
  3. Past bariatric surgery
  4. Women who are pregnant, lactating or planning pregnancy
  5. History or known present diagnosis of cardiovascular (i.e.hypertension (systolic/diastolic blood pressure: >/= 140/90 mmHg), endocrine (i.e. type 1 and type 2 diabetes mellitus), gastrointestinal, hematological (G6PD and coagulation disorders), hepatic (hepatitis B and C), malignant, renal, respiratory, thyroid or other relevant disorders which may affect the outcomes of interested in consultation with the researchers involved
  6. Prescribed and regularly taking western or traditional medicine which may affect the outcomes of interest in consultation with the researchers involved
  7. History or present diagnosis of HIV and/or tuberculosis.
  8. Drug abuse within the last 5 years
  9. Taking dietary supplements which may affect study outcomes one month prior to their first visit (e.g. protein supplements, omega-3/6 supplements or other nutritional supplements such as Ensure, Anlene etc.)
  10. Following any special diets which may interfere with intervention procedures (for medical, aesthetic or religious reasons)
  11. Allergy to nuts, seeds, legumes (soy, pea), cereal (wheat gluten), beef, pork, chicken or any other ingredients present in foods provided for intervention
  12. Excessive alcoholic beverage consumption > 2 servings per day (1 serving is defined as 360 mL beer, 150 mL wine or 45 mL distilled spirits)
  13. Smoking (cigarette, e-cigarette, cigar, pipe) or vaping
  14. Exercising vigorously over the past 3 months
  15. Staff of Prince September Pte. Ltd. (Pinduoduo Inc.) and/or Singapore Institute of Food and Biotechnology Innovation (SIFBI)

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel 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.
Experimental: Animal-based meats (ABMD group)
Participants will be instructed to substitute protein-rich foods consumed habitually with animal-based meats (ABMD group).
Dietary supplement: Animal-based meats
Animal-based meats from beef, pork and chicken
Experimental: Plant-based meat alternatives (PBMD group)
Participants will be instructed to substitute protein-rich foods consumed habitually with Plant-based meat alternatives (PBMD group).
Dietary supplement: Plant-based meat alternatives
Plant-based meat alternatives of beef, pork and chicken

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
Change in metabolic health risk indicators
Time Frame: Pre- and Post-intervention (Week 8)
Glucose
Pre- and Post-intervention (Week 8)
Change in cardiovascular health risk indicators
Time Frame: Pre- and Post-intervention (Week 8)
Insulin
Pre- and Post-intervention (Week 8)
Change in metabolic health risk indicators
Time Frame: Pre- and Post-intervention (Week 8)
Fructosamine
Pre- and Post-intervention (Week 8)
Change in metabolic health risk indicators
Time Frame: Day -2 (from Week 0) to Day 12. 14 days in total
14-day continuous blood glucose monitoring (subgroup; n = 48)
Day -2 (from Week 0) to Day 12. 14 days in total
Change in cardiovascular health risk indicators
Time Frame: Pre- and Post-intervention (Week 8)
Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides
Pre- and Post-intervention (Week 8)
Change in cardiovascular health risk indicators
Time Frame: Pre- and Post-intervention (Week 8)
Clinic blood pressure and ambulatory blood pressure (subgroup; n = 48)
Pre- and Post-intervention (Week 8)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in protein metabolism-related biomarkers in plasma/serum
Time Frame: Pre- and Post-intervention (Week 8)
Protein and amino acid profile
Pre- and Post-intervention (Week 8)
Change in protein metabolism-related biomarkers in plasma/serum
Time Frame: Pre- and Post-intervention (Week 8)
Urea nitrogen
Pre- and Post-intervention (Week 8)
Change in protein metabolism-related biomarkers in plasma/serum
Time Frame: Pre- and Post-intervention (Week 8)
Creatinine
Pre- and Post-intervention (Week 8)
Change in protein metabolism-related biomarkers in plasma/serum
Time Frame: Pre- and Post-intervention (Week 8)
Albumin
Pre- and Post-intervention (Week 8)
Change in inflammation-related risk indicators
Time Frame: Pre- and Post-intervention (Week 8)
High sensitivity CRP
Pre- and Post-intervention (Week 8)
Change in anthropometric measurements
Time Frame: Pre- and Post-intervention (Week 8)
Weight
Pre- and Post-intervention (Week 8)
Change in anthropometric measurements
Time Frame: Pre- and Post-intervention (Week 8)
Waist and hip circumference
Pre- and Post-intervention (Week 8)
Change in body composition
Time Frame: Pre- and Post-intervention (Week 8)
Dual Energy X-ray absorptiometry
Pre- and Post-intervention (Week 8)

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.
Clinical Nutrition Research Centre, Singapore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Prince September Pte. Ltd.

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)

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.
June 17, 2022

Primary Completion (Anticipated)

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.
May 1, 2023

Study Completion (Anticipated)

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.
May 1, 2023

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).
June 23, 2022

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.
July 4, 2022

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.
July 7, 2022

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.
July 7, 2022

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.
July 4, 2022

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.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 2022/00278

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings