Singapore Healthy Alternative Protein Evaluation Study

NCT ID: NCT05446753

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-17
• Study Completion Date: 2023-05-31

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.

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Protein Metabolism Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Animal-based meats (ABMD group)

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

Group Type: EXPERIMENTAL

Animal-based meats

Intervention Type: DIETARY_SUPPLEMENT

Animal-based meats from beef, pork and chicken

Plant-based meat alternatives (PBMD group)

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

Group Type: EXPERIMENTAL

Plant-based meat alternatives

Intervention Type: DIETARY_SUPPLEMENT

Plant-based meat alternatives of beef, pork and chicken

Interventions

Animal-based meats

Animal-based meats from beef, pork and chicken

Intervention Type: DIETARY_SUPPLEMENT

Plant-based meat alternatives

Plant-based meat alternatives of beef, pork and chicken

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prince September Pte. Ltd.

UNKNOWN

Sponsor Role: collaborator

Singapore Institute of Food and Biotechnology Innovation

OTHER_GOV

Sponsor Role: lead

Responsible Party

JeyaKumar Henry

Deputy Executive Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Nutrition Research Centre

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Jeyakumar C Henry, PhD

Role: CONTACT

jeya_henry@sifbi.a-star.edu.sg

6407 0793

Facility Contacts

Jeyakumar C Henry, PhD

Role: primary

jeya_henry@sifbi.a-star.edu.sg

6407 0793

References

Toh DWK, Fu AS, Mehta KA, Lam NYL, Haldar S, Henry CJ. Plant-Based Meat Analogs and Their Effects on Cardiometabolic Health: An 8-Week Randomized Controlled Trial Comparing Plant-Based Meat Analogs With Their Corresponding Animal-Based Foods. Am J Clin Nutr. 2024 Jun;119(6):1405-1416. doi: 10.1016/j.ajcnut.2024.04.006. Epub 2024 Apr 8.

Reference Type: DERIVED

PMID: 38599522 (View on PubMed)

Other Identifiers

2022/00278

Identifier Type: -

Identifier Source: org_study_id