Singapore Healthy Alternative Protein Evaluation Study

NCT05446753 | Unknown

• 1 other identifier: 2022/00278
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Change in metabolic health risk indicators

  Glucose

  Pre- and Post-intervention (Week 8)

• Change in cardiovascular health risk indicators

  Insulin

  Pre- and Post-intervention (Week 8)

• Change in metabolic health risk indicators

  Fructosamine

  Pre- and Post-intervention (Week 8)

• Change in metabolic health risk indicators

  14-day continuous blood glucose monitoring (subgroup; n = 48)

  Day -2 (from Week 0) to Day 12. 14 days in total

• Change in cardiovascular health risk indicators

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

  Pre- and Post-intervention (Week 8)

• Change in cardiovascular health risk indicators

  Clinic blood pressure and ambulatory blood pressure (subgroup; n = 48)

  Pre- and Post-intervention (Week 8)

Secondary Outcomes (8)

• Change in protein metabolism-related biomarkers in plasma/serum

  Pre- and Post-intervention (Week 8)

• Change in protein metabolism-related biomarkers in plasma/serum

  Pre- and Post-intervention (Week 8)

• Change in protein metabolism-related biomarkers in plasma/serum

  Pre- and Post-intervention (Week 8)

• Change in protein metabolism-related biomarkers in plasma/serum

  Pre- and Post-intervention (Week 8)

• Change in inflammation-related risk indicators

  Pre- and Post-intervention (Week 8)

Study Arms (2)

Animal-based meats (ABMD group)

EXPERIMENTAL

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

Dietary Supplement: Animal-based meats

Plant-based meat alternatives (PBMD group)

EXPERIMENTAL

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

Dietary Supplement: Plant-based meat alternatives

Interventions

Animal-based meats DIETARY_SUPPLEMENT

Animal-based meats from beef, pork and chicken

Animal-based meats (ABMD group)

Plant-based meat alternatives DIETARY_SUPPLEMENT

Plant-based meat alternatives of beef, pork and chicken

Plant-based meat alternatives (PBMD group)

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese males and females
• Age \> 30 to \</= 70 years
• Habitually consuming between 2 and 4 servings of protein-rich foods daily (\~20 g protein per serving)
• Raised blood glucose (fasting glucose \>/= 5.4 and \</= 7.0 mmol/L) and/or (HbA1c \>/= 5.7 and \</= 6.4 %)
• Fully vaccinated against COVID-19 (referred to as having completed a minimum of 2 doses Pfizer-BioNTech / Comirnaty / Moderna or 3 doses Sinovac-CoronaVac)
• Ability to give an informed consent
• Willing to adhere to study intervention procedures

You may not qualify if:

• Obese: BMI (\>/= 27.5 kg/m2) and/or waist circumference (\>/= 102 cm for male; \>/= 88 cm for female)
• Significant weight change (± 5 % body weight) during the past 3 months
• Past bariatric surgery
• Women who are pregnant, lactating or planning pregnancy
• 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
• Prescribed and regularly taking western or traditional medicine which may affect the outcomes of interest in consultation with the researchers involved
• History or present diagnosis of HIV and/or tuberculosis.
• Drug abuse within the last 5 years
• 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.)
• Following any special diets which may interfere with intervention procedures (for medical, aesthetic or religious reasons)
• Allergy to nuts, seeds, legumes (soy, pea), cereal (wheat gluten), beef, pork, chicken or any other ingredients present in foods provided for intervention
• Excessive alcoholic beverage consumption \> 2 servings per day (1 serving is defined as 360 mL beer, 150 mL wine or 45 mL distilled spirits)
• Smoking (cigarette, e-cigarette, cigar, pipe) or vaping
• Exercising vigorously over the past 3 months
• Staff of Prince September Pte. Ltd. (Pinduoduo Inc.) and/or Singapore Institute of Food and Biotechnology Innovation (SIFBI)

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead
• Prince September Pte. Ltd.: collaborator

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

RECRUITING

Related Publications (1)

• 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.

  PMID: 38599522 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Interventions

Meat Substitutes

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Jeyakumar C Henry, PhD

CONTACT

6407 0793; jeya_henry@sifbi.a-star.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Executive Director

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 7, 2022
• Study Start: June 17, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)