Cardiovascular Diseases, Diabetes Mellitus, Protein Metabolism Disorder
Conditions
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTAnimal-based meats
Animal-based meats from beef, pork and chicken
DIETARY_SUPPLEMENTPlant-based meat alternatives
Plant-based meat alternatives of beef, pork and chicken
Sponsors
Prince September Pte. Ltd.
Singapore Institute of Food and Biotechnology Innovation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in metabolic health risk indicators | Pre- and Post-intervention (Week 8) | Glucose |
| Change in cardiovascular health risk indicators | Pre- and Post-intervention (Week 8) | Insulin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in protein metabolism-related biomarkers in plasma/serum | Pre- and Post-intervention (Week 8) | Protein and amino acid profile |
| Change in inflammation-related risk indicators | Pre- and Post-intervention (Week 8) | High sensitivity CRP |
| Change in anthropometric measurements | Pre- and Post-intervention (Week 8) | Weight |
| Change in body composition | Pre- and Post-intervention (Week 8) | Dual Energy X-ray absorptiometry |
Countries
Singapore
Contacts
Primary ContactJeyakumar C Henry, PhD
Outcome results
None listed