SHAPES: Singapore Healthy Alternative Protein Evaluation Study

• Sponsor: Clinical Nutrition Research Centre, Singapore (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05446753
• Collaborator: Prince September Pte. Ltd. (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.4
• Patients Per Site Per Month: 9.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Cardiovascular Diseases; Protein Metabolism Disorder	Dietary Supplement: Animal-based meats; Dietary Supplement: Plant-based meat alternatives	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Basic Science
• Official Title: Singapore Healthy Alternative Protein Evaluation Study
• Actual Study Start Date: Jun 17, 2022
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in metabolic health risk indicators [Pre- and Post-intervention (Week 8)]

   Glucose

2. Change in cardiovascular health risk indicators [Pre- and Post-intervention (Week 8)]

   Insulin

3. Change in metabolic health risk indicators [Pre- and Post-intervention (Week 8)]

   Fructosamine

4. 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)

5. Change in cardiovascular health risk indicators [Pre- and Post-intervention (Week 8)]

   Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides

6. 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

1. Change in protein metabolism-related biomarkers in plasma/serum [Pre- and Post-intervention (Week 8)]

   Protein and amino acid profile

2. Change in protein metabolism-related biomarkers in plasma/serum [Pre- and Post-intervention (Week 8)]

   Urea nitrogen

3. Change in protein metabolism-related biomarkers in plasma/serum [Pre- and Post-intervention (Week 8)]

   Creatinine

4. Change in protein metabolism-related biomarkers in plasma/serum [Pre- and Post-intervention (Week 8)]

   Albumin

5. Change in inflammation-related risk indicators [Pre- and Post-intervention (Week 8)]

   High sensitivity CRP

6. Change in anthropometric measurements [Pre- and Post-intervention (Week 8)]

   Weight

7. Change in anthropometric measurements [Pre- and Post-intervention (Week 8)]

   Waist and hip circumference

8. Change in body composition [Pre- and Post-intervention (Week 8)]

   Dual Energy X-ray absorptiometry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Nutrition Research Centre	Singapore		Singapore	117599

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JeyaKumar Henry, Deputy Executive Director, Clinical Nutrition Research Centre, Singapore
• ClinicalTrials.gov Identifier: NCT05446753
• Other Study ID Numbers: 2022/00278
• First Posted: Jul 7, 2022
• Last Update Posted: Jul 7, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases; Metabolic Diseases

Study Results

No Results Posted as of Jul 7, 2022