Singapore Healthy Alternative Protein Evaluation Study

Cardiovascular Diseases Clinical Trial

— SHAPES  

Official title:

Singapore Healthy Alternative Protein Evaluation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05446753
• Other study ID #: 2022/00278
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: May 2023

Study information

• Verified date: July 2022
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: Jeyakumar C Henry, PhD
• Phone: 6407 0793
• Email: jeya_henry[@]sifbi.a-star.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Metabolic Diseases
• Protein Metabolism Disorder

Intervention

Dietary Supplement:
• Animal-based meats
Animal-based meats from beef, pork and chicken
• Plant-based meat alternatives
Plant-based meat alternatives of beef, pork and chicken

Locations

Country	Name	City	State
Singapore	Clinical Nutrition Research Centre	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore	Prince September Pte. Ltd.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in metabolic health risk indicators	Glucose	Pre- and Post-intervention (Week 8)
Primary	Change in cardiovascular health risk indicators	Insulin	Pre- and Post-intervention (Week 8)
Primary	Change in metabolic health risk indicators	Fructosamine	Pre- and Post-intervention (Week 8)
Primary	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
Primary	Change in cardiovascular health risk indicators	Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides	Pre- and Post-intervention (Week 8)
Primary	Change in cardiovascular health risk indicators	Clinic blood pressure and ambulatory blood pressure (subgroup; n = 48)	Pre- and Post-intervention (Week 8)
Secondary	Change in protein metabolism-related biomarkers in plasma/serum	Protein and amino acid profile	Pre- and Post-intervention (Week 8)
Secondary	Change in protein metabolism-related biomarkers in plasma/serum	Urea nitrogen	Pre- and Post-intervention (Week 8)
Secondary	Change in protein metabolism-related biomarkers in plasma/serum	Creatinine	Pre- and Post-intervention (Week 8)
Secondary	Change in protein metabolism-related biomarkers in plasma/serum	Albumin	Pre- and Post-intervention (Week 8)
Secondary	Change in inflammation-related risk indicators	High sensitivity CRP	Pre- and Post-intervention (Week 8)
Secondary	Change in anthropometric measurements	Weight	Pre- and Post-intervention (Week 8)
Secondary	Change in anthropometric measurements	Waist and hip circumference	Pre- and Post-intervention (Week 8)
Secondary	Change in body composition	Dual Energy X-ray absorptiometry	Pre- and Post-intervention (Week 8)