Singapore Healthy Alternative Protein Evaluation Study

Not Applicable

• Conditions: Diabetes Mellitus; Cardiovascular Diseases; Protein Metabolism Disorder
• Interventions: Dietary Supplement: Plant-based meat alternatives; Dietary Supplement: Animal-based meats

• Registration Number: NCT05446753
• Lead Sponsor: Clinical Nutrition Research Centre, Singapore

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-17
• Study First Submitted: 2022-06-23
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-04
• Last Update Submitted: 2022-07-04
• Study First Posted: 2022-07-07
• Last Update Posted: 2022-07-07
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plant-based meat alternatives (PBMD group)	Plant-based meat alternatives	Participants will be instructed to substitute protein-rich foods consumed habitually with Plant-based meat alternatives (PBMD group).
Animal-based meats (ABMD group)	Animal-based meats	Participants will be instructed to substitute protein-rich foods consumed habitually with animal-based meats (ABMD group).

Primary Outcome Measures

Name	Time	Method
Change in metabolic health risk indicators	Day -2 (from Week 0) to Day 12. 14 days in total	14-day continuous blood glucose monitoring (subgroup; n = 48)
Change in cardiovascular health risk indicators	Pre- and Post-intervention (Week 8)	Clinic blood pressure and ambulatory blood pressure (subgroup; n = 48)

Secondary Outcome Measures

Name	Time	Method
Change in protein metabolism-related biomarkers in plasma/serum	Pre- and Post-intervention (Week 8)	Albumin
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)	Waist and hip circumference
Change in body composition	Pre- and Post-intervention (Week 8)	Dual Energy X-ray absorptiometry

Trial Locations

Locations (1)

Clinical Nutrition Research Centre; 🇸🇬 Singapore, Singapore