Singapore Healthy Alternative Protein Evaluation Study

Study Overview
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Brief Summary
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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.

Official Title
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Singapore Healthy Alternative Protein Evaluation Study

Conditions
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Diabetes Mellitus, Cardiovascular Diseases, Protein Metabolism Disorder

Intervention / Treatment
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* Dietary Supplement: Animal-based meats
* Dietary Supplement: Plant-based meat alternatives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Animal-based meats (ABMD group)<br>Participants will be instructed to substitute protein-rich foods consumed habitually with animal-based meats (ABMD group). | Dietary Supplement: Animal-based meats<br>* Animal-based meats from beef, pork and chicken<br>|
| Experimental: Plant-based meat alternatives (PBMD group)<br>Participants will be instructed to substitute protein-rich foods consumed habitually with Plant-based meat alternatives (PBMD group). | Dietary Supplement: Plant-based meat alternatives<br>* Plant-based meat alternatives of beef, pork and chicken<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metabolic health risk indicators | Glucose | Pre- and Post-intervention (Week 8) | 
| Change in cardiovascular health risk indicators | Insulin | Pre- and Post-intervention (Week 8) | 
| Change in metabolic health risk indicators | Fructosamine | Pre- and Post-intervention (Week 8) | 
| Change in metabolic health risk indicators | 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 | Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides | Pre- and Post-intervention (Week 8) | 
| Change in cardiovascular health risk indicators | Clinic blood pressure and ambulatory blood pressure (subgroup; n = 48) | Pre- and Post-intervention (Week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in protein metabolism-related biomarkers in plasma/serum | Protein and amino acid profile | Pre- and Post-intervention (Week 8) | 
| Change in protein metabolism-related biomarkers in plasma/serum | Urea nitrogen | Pre- and Post-intervention (Week 8) | 
| Change in protein metabolism-related biomarkers in plasma/serum | Creatinine | Pre- and Post-intervention (Week 8) | 
| Change in protein metabolism-related biomarkers in plasma/serum | Albumin | Pre- and Post-intervention (Week 8) | 
| Change in inflammation-related risk indicators | High sensitivity CRP | Pre- and Post-intervention (Week 8) | 
| Change in anthropometric measurements | Weight | Pre- and Post-intervention (Week 8) | 
| Change in anthropometric measurements | Waist and hip circumference | Pre- and Post-intervention (Week 8) | 
| Change in body composition | Dual Energy X-ray absorptiometry | Pre- and Post-intervention (Week 8) |