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Diabetes MellitusSHAPESNCT05446753

Singapore Healthy Alternative Protein Evaluation Study

A study testing Animal-based meats and Plant-based meat alternatives in people with Diabetes Mellitus and Cardiovascular Diseases, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 70 yearsHealthy volunteers can take part
What is being tested?
Animal-based meats and Plant-based meat alternatives
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSingapore
Study dates
17 Jun 2022to May 2023
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 30 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Obese: BMI (>/= 27.5 kg/m2) and/or waist circumference (>/= 102 cm for male; >/= 88 cm for female)
  • Significant weight change (± 5 % body weight) during the past 3 months
  • Past bariatric surgery
  • Women who are pregnant, lactating or planning pregnancy
  • 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
  • Prescribed and regularly taking western or traditional medicine which may affect the outcomes of interest in consultation with the researchers involved
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  • History or present diagnosis of HIV and/or tuberculosis.
  • Drug abuse within the last 5 years
  • 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.)
  • Following any special diets which may interfere with intervention procedures (for medical, aesthetic or religious reasons)
  • Allergy to nuts, seeds, legumes (soy, pea), cereal (wheat gluten), beef, pork, chicken or any other ingredients present in foods provided for intervention
  • Excessive alcoholic beverage consumption > 2 servings per day (1 serving is defined as 360 mL beer, 150 mL wine or 45 mL distilled spirits)
  • Smoking (cigarette, e-cigarette, cigar, pipe) or vaping
  • Exercising vigorously over the past 3 months
  • Staff of Prince September Pte. Ltd. (Pinduoduo Inc.) and/or Singapore Institute of Food and Biotechnology Innovation (SIFBI)

Trial locations and contacts

1 site in 1 country.

Jeyakumar C Henry, PhD contact

6407 0793

jeya_henry@sifbi.a-star.edu.sg

Singapore1 site, 1 recruiting

  • Clinical Nutrition Research Centre

    Singapore, 117599

    Jeyakumar C Henry, PhD, 6407 0793, jeya_henry@sifbi.a-star.edu.sg

    Recruiting

Other trials in Singapore

About this study

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.

Being tested
Animal-based meats, Plant-based meat alternatives
Medical subject headings
Diabetes Mellitus, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Animal-based meatsDietary supplement

    Animal-based meats from beef, pork and chicken

  • Plant-based meat alternativesDietary supplement

    Plant-based meat alternatives of beef, pork and chicken

Study groups in NCT05446753
Study groupRoleWhat they receive
Animal-based meats (ABMD group)ExperimentalParticipants will be instructed to substitute protein-rich foods consumed habitually with animal-based meats (ABMD group).
Receives: Dietary Supplement: Animal-based meats
Plant-based meat alternatives (PBMD group)ExperimentalParticipants will be instructed to substitute protein-rich foods consumed habitually with Plant-based meat alternatives (PBMD group).
Receives: Dietary Supplement: Plant-based meat alternatives

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in metabolic health risk indicators

    Glucose

    Measured: Pre- and Post-intervention (Week 8)

  2. Change in cardiovascular health risk indicators

    Insulin

    Measured: Pre- and Post-intervention (Week 8)

  3. Change in metabolic health risk indicators

    Fructosamine

    Measured: Pre- and Post-intervention (Week 8)

  4. Change in metabolic health risk indicators

    14-day continuous blood glucose monitoring (subgroup; n = 48)

    Measured: Day -2 (from Week 0) to Day 12. 14 days in total

  5. Change in cardiovascular health risk indicators

    Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides

    Measured: Pre- and Post-intervention (Week 8)

  6. Change in cardiovascular health risk indicators

    Clinic blood pressure and ambulatory blood pressure (subgroup; n = 48)

    Measured: Pre- and Post-intervention (Week 8)

Secondary outcomes (8)

  1. Change in protein metabolism-related biomarkers in plasma/serum

    Protein and amino acid profile

    Measured: Pre- and Post-intervention (Week 8)

  2. Change in protein metabolism-related biomarkers in plasma/serum

    Urea nitrogen

    Measured: Pre- and Post-intervention (Week 8)

  3. Change in protein metabolism-related biomarkers in plasma/serum

    Creatinine

    Measured: Pre- and Post-intervention (Week 8)

  4. Change in protein metabolism-related biomarkers in plasma/serum

    Albumin

    Measured: Pre- and Post-intervention (Week 8)

  5. Change in inflammation-related risk indicators

    High sensitivity CRP

    Measured: Pre- and Post-intervention (Week 8)

  6. Change in anthropometric measurements

    Weight

    Measured: Pre- and Post-intervention (Week 8)

  7. Change in anthropometric measurements

    Waist and hip circumference

    Measured: Pre- and Post-intervention (Week 8)

  8. Change in body composition

    Dual Energy X-ray absorptiometry

    Measured: Pre- and Post-intervention (Week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2022
  2. Study start17 Jun 2022
  3. Primary completionMay 2023 (estimated)
  4. Study completionMay 2023 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05446753
Sponsor's protocol ID
2022/00278
Acronym
SHAPES
Status last verified
Jul 2022
First submitted
23 Jun 2022
Last updated
7 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fu AS, Osman F, Cameron-Smith D, Lam NYL, Mehta KA, Leow MK, Haldar S, Henry CJ, Toh DWK. Micronutrient intake and status of adults consuming plant-based meat analogues or animal-based meats as primary protein source: An 8-week randomized controlled trial. Clin Nutr. 2026 Apr;59:106610. doi: 10.1016/j.clnu.2026.106610. Epub 2026 Feb 25.

    PubMed 41785660

  • Toh DWK, Fu AS, Mehta KA, Lam NYL, Haldar S, Henry CJ. Plant-Based Meat Analogs and Their Effects on Cardiometabolic Health: An 8-Week Randomized Controlled Trial Comparing Plant-Based Meat Analogs With Their Corresponding Animal-Based Foods. Am J Clin Nutr. 2024 Jun;119(6):1405-1416. doi: 10.1016/j.ajcnut.2024.04.006. Epub 2024 Apr 8.

    PubMed 38599522

Questions about this trial

What is this clinical trial studying?

A study testing Animal-based meats and Plant-based meat alternatives in people with Diabetes Mellitus and Cardiovascular Diseases, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.

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 7 inclusion and 15 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 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Jeyakumar C Henry, PhD (6407 0793, jeya_henry@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?

Change in metabolic health risk indicators (time frame: Pre- and Post-intervention (Week 8)). 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?

On the ClinicalTrials.gov record for NCT05446753, which also lists 2 linked publications.

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 7 Jul 2022.

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Singapore Healthy Alternative Protein Evaluation Study | AzTrials