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Singapore Healthy Alternative Protein Evaluation Study (SHAPES)

Primary Purpose

Diabetes Mellitus, Cardiovascular Diseases, Protein Metabolism Disorder

Status

Recruiting

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Animal-based meats

Plant-based meat alternatives

About this trial

This is an interventional basic science trial for Diabetes Mellitus

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

Clinical Nutrition Research CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Animal-based meats (ABMD group)

Plant-based meat alternatives (PBMD group)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in metabolic health risk indicators

Glucose

Change in cardiovascular health risk indicators

Insulin

Change in metabolic health risk indicators

Fructosamine

Change in metabolic health risk indicators

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

Change in cardiovascular health risk indicators

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

Change in cardiovascular health risk indicators

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

Secondary Outcome Measures

Change in protein metabolism-related biomarkers in plasma/serum

Protein and amino acid profile

Change in protein metabolism-related biomarkers in plasma/serum

Urea nitrogen

Change in protein metabolism-related biomarkers in plasma/serum

Creatinine

Change in protein metabolism-related biomarkers in plasma/serum

Albumin

Change in inflammation-related risk indicators

High sensitivity CRP

Change in anthropometric measurements

Weight

Change in anthropometric measurements

Waist and hip circumference

Change in body composition

Dual Energy X-ray absorptiometry

Full Information

NCT ID

NCT05446753

First Posted

June 23, 2022

Last Updated

July 4, 2022

Sponsor

Clinical Nutrition Research Centre, Singapore

Collaborators

Prince September Pte. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05446753

Brief Title

Singapore Healthy Alternative Protein Evaluation Study

Acronym

SHAPES

Official Title

Singapore Healthy Alternative Protein Evaluation Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 17, 2022 (Actual)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Clinical Nutrition Research Centre, Singapore

Collaborators

Prince September Pte. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Cardiovascular Diseases, Protein Metabolism Disorder

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Animal-based meats (ABMD group)

Arm Type

Experimental

Arm Description

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

Arm Title

Plant-based meat alternatives (PBMD group)

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Animal-based meats

Intervention Description

Animal-based meats from beef, pork and chicken

Intervention Type

Dietary Supplement

Intervention Name(s)

Plant-based meat alternatives

Intervention Description

Plant-based meat alternatives of beef, pork and chicken

Primary Outcome Measure Information:

Title

Change in metabolic health risk indicators

Description

Glucose

Time Frame

Pre- and Post-intervention (Week 8)

Title

Change in cardiovascular health risk indicators

Description

Insulin

Time Frame

Pre- and Post-intervention (Week 8)

Title

Change in metabolic health risk indicators

Description

Fructosamine

Time Frame

Pre- and Post-intervention (Week 8)

Title

Change in metabolic health risk indicators

Description

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

Time Frame

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

Title

Change in cardiovascular health risk indicators

Description

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

Time Frame

Pre- and Post-intervention (Week 8)

Title

Change in cardiovascular health risk indicators

Description

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

Time Frame

Pre- and Post-intervention (Week 8)

Secondary Outcome Measure Information:

Title

Change in protein metabolism-related biomarkers in plasma/serum

Description

Protein and amino acid profile

Time Frame

Pre- and Post-intervention (Week 8)

Title

Change in protein metabolism-related biomarkers in plasma/serum

Description

Urea nitrogen

Time Frame

Pre- and Post-intervention (Week 8)

Title

Change in protein metabolism-related biomarkers in plasma/serum

Description

Creatinine

Time Frame

Pre- and Post-intervention (Week 8)

Title

Change in protein metabolism-related biomarkers in plasma/serum

Description

Albumin

Time Frame

Pre- and Post-intervention (Week 8)

Title

Change in inflammation-related risk indicators

Description

High sensitivity CRP

Time Frame

Pre- and Post-intervention (Week 8)

Title

Change in anthropometric measurements

Description

Weight

Time Frame

Pre- and Post-intervention (Week 8)

Title

Change in anthropometric measurements

Description

Waist and hip circumference

Time Frame

Pre- and Post-intervention (Week 8)

Title

Change in body composition

Description

Dual Energy X-ray absorptiometry

Time Frame

Pre- and Post-intervention (Week 8)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeyakumar C Henry, PhD

Phone

6407 0793

jeya_henry@sifbi.a-star.edu.sg

Facility Information:

Facility Name

Clinical Nutrition Research Centre

City

Singapore

ZIP/Postal Code

117599

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeyakumar C Henry, PhD

Phone

6407 0793

jeya_henry@sifbi.a-star.edu.sg

12. IPD Sharing Statement

Plan to Share IPD

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