Singapore Healthy Alternative Protein Evaluation Study (SHAPES)

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: Recruiting
• Conditions: Cardiovascular Diseases; Diabetes Mellitus; Protein Metabolism Disorder
• Intervention / Treatment: Dietary supplement: Animal-based meats; Dietary supplement: Plant-based meat alternatives

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeyakumar C Henry, PhD; Phone Number: 6407 0793; Email: jeya_henry@sifbi.a-star.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 117599
    • Recruiting
    • Clinical Nutrition Research Centre
    • Contact: Jeyakumar C Henry, PhD; Phone Number: 6407 0793; Email: jeya_henry@sifbi.a-star.edu.sg

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)

Collaborators and Investigators

• Sponsor: Clinical Nutrition Research Centre, Singapore
• Collaborators: Prince September Pte. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Metabolic Diseases
• Other Study ID 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