Singapore Healthy Alternative Protein Evaluation Study (SHAPES)

Clinical Nutrition Research Centre, Singapore

Status: Enrolling

Conditions: Protein Metabolism Disorder; Diabetes Mellitus; Cardiovascular Diseases

Treatments: Dietary Supplement: Animal-based meats; Dietary Supplement: Plant-based meat alternatives

Study type: Interventional

Funder types: Other

Identifiers

NCT05446753

2022/00278

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Animal-based meats (ABMD group)

Experimental group

Description:

Participants will be instructed to substitute protein-rich foods consumed habitually with animal-based meats (ABMD group).

Treatment:

Dietary Supplement: Animal-based meats

Plant-based meat alternatives (PBMD group)

Experimental group

Description:

Participants will be instructed to substitute protein-rich foods consumed habitually with Plant-based meat alternatives (PBMD group).

Treatment:

Dietary Supplement: Plant-based meat alternatives