Clinical trial NCT05446753: Singapore Healthy Alternative Protein Evaluation Study
Official title: Singapore Healthy Alternative Protein Evaluation Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Cardiovascular Diseases
Protein Metabolism Disorder
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
Collaborators: name: Prince September Pte. Ltd.
First posted: 2022-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in metabolic health risk indicators
timeFrame: Pre- and Post-intervention (Week 8)
measure: Change in cardiovascular health risk indicators
timeFrame: Pre- and Post-intervention (Week 8)
measure: Change in metabolic health risk indicators
timeFrame: Pre- and Post-intervention (Week 8)
measure: Change in metabolic health risk indicators
timeFrame: Day -2 (from Week 0) to Day 12. 14 days in total
measure: Change in cardiovascular health risk indicators
timeFrame: Pre- and Post-intervention (Week 8)
measure: Change in cardiovascular health risk indicators
timeFrame: Pre- and Post-intervention (Week 8)
Secondary outcomes:
measure: Change in protein metabolism-related biomarkers in plasma/serum
timeFrame: Pre- and Post-intervention (Week 8)
measure: Change in protein metabolism-related biomarkers in plasma/serum
timeFrame: Pre- and Post-intervention (Week 8)
measure: Change in protein metabolism-related biomarkers in plasma/serum
timeFrame: Pre- and Post-intervention (Week 8)
measure: Change in protein metabolism-related biomarkers in plasma/serum
timeFrame: Pre- and Post-intervention (Week 8)
measure: Change in inflammation-related risk indicators
timeFrame: Pre- and Post-intervention (Week 8)
measure: Change in anthropometric measurements
timeFrame: Pre- and Post-intervention (Week 8)
measure: Change in anthropometric measurements
timeFrame: Pre- and Post-intervention (Week 8)
measure: Change in body composition
timeFrame: Pre- and Post-intervention (Week 8)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
References: