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Efficacy of Pigmented Rice on Reducing Cardiometabolic Risk Factors Among Filipino Adults

Primary Purpose

Dyslipidemias, Overweight or Obesity, Hyperglycaemia (Non Diabetic)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pigmented rice
White Rice
Sponsored by
University of Santo Tomas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dyslipidemias focused on measuring pigmented rice, dyslipidemia, hyperglycemia

Eligibility Criteria

20 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged 20-59 years. Body mass index between 18.5 -35 kg/m2 Elevated cholesterol (total cholesterol >200 mg/dL or LDL cholesterol 130-190 mg/dL), and/or impaired fasting glucose (100-125mg/dL) Eat rice as a staple food at least twice per day Exclusion Criteria: Are pregnant or lactating Regularly consume pigmented rice (two meals per day in the past 4 weeks) Have cardiovascular disease (hypertension, stroke, ischemic heart disease, myocardial infarction, or congestive heart failure) or diabetes mellitus Take cholesterol or glucose-lowering medications Have elevated blood pressure (>130/80 mmHg) Have an illness that may influence lipid metabolism or metabolic rate (liver cirrhosis, pancreatitis, chronic kidney disease, hyperthyroidism, hypothyroidism) Take supplements that may influence lipids and glucose levels (including polyphenols) Are on a strict diet regimen (calorie-restricted or excluding food groups, examples: (Examples: Ketogenic diet, Intermittent fasting, No Rice diet) Have an active lifestyle (Ex. Goes to the gym daily, regularly (≥3 times a week) and perform vigorous activities such as lifting weights, swimming, cycling fast or uphill, or running, or athlete)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Pigmented Rice

    White Rice

    Arm Description

    Cooked black pigmented rice will be consumed for six weeks (twice per day)

    Cooked white rice will be consumed by the control group for six weeks (twice per day)

    Outcomes

    Primary Outcome Measures

    Change in Lipid Levels
    Total cholesterol, Low-density lipoprotein, high-density lipoprotein, triglycerides
    Change in Glucose Level
    Fasting blood glucose

    Secondary Outcome Measures

    Change in Weight (kg)
    Weight in kilograms
    Change in Waist Circumference (cm)
    Waist circumference in centimeters
    Change in Hip Circumference (cm)
    Hip Circumference in centimeters
    Change in Waist:Hip (W:H ratio)
    Waist and hip measurement will be combined to report W:H ratio

    Full Information

    First Posted
    October 10, 2023
    Last Updated
    October 19, 2023
    Sponsor
    University of Santo Tomas
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06092632
    Brief Title
    Efficacy of Pigmented Rice on Reducing Cardiometabolic Risk Factors Among Filipino Adults
    Official Title
    Efficacy of Pigmented Rice on Reducing Cardiometabolic Risk Factors Among Filipino Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 13, 2023 (Anticipated)
    Primary Completion Date
    August 30, 2024 (Anticipated)
    Study Completion Date
    November 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Santo Tomas

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary purpose of this clinical trial is to investigate whether the consumption of pigmented rice (black rice) in the diet improves cardiovascular health, specifically body weight, lipids, and glucose levels. It also aims to know whether people enjoyed eating pigmented rice and if they would continue eating it.
    Detailed Description
    The goal of this clinical trial is to test if pigmented rice consumption can lower the cardiometabolic risk factors of adults. The main question[s] it aims to answer are: Will pigmented rice significantly reduce lipid levels compared to white rice after six weeks? Will pigmented rice significantly reduce glucose levels compared to white rice after six weeks? Will pigmented rice significantly reduce weight and waist-hip ratio levels compared to white rice after six weeks? What are the participants' experiences in consuming pigmented rice? Participants will consume black-pigmented rice for six weeks while maintaining their usual physical activity. Researchers will compare the white rice group and the black rice group to see if lowers cardiometabolic risk factors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemias, Overweight or Obesity, Hyperglycaemia (Non Diabetic)
    Keywords
    pigmented rice, dyslipidemia, hyperglycemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pigmented Rice
    Arm Type
    Experimental
    Arm Description
    Cooked black pigmented rice will be consumed for six weeks (twice per day)
    Arm Title
    White Rice
    Arm Type
    Placebo Comparator
    Arm Description
    Cooked white rice will be consumed by the control group for six weeks (twice per day)
    Intervention Type
    Other
    Intervention Name(s)
    Pigmented rice
    Other Intervention Name(s)
    Black Rice
    Intervention Description
    Cooked black rice
    Intervention Type
    Other
    Intervention Name(s)
    White Rice
    Intervention Description
    Cooked white rice
    Primary Outcome Measure Information:
    Title
    Change in Lipid Levels
    Description
    Total cholesterol, Low-density lipoprotein, high-density lipoprotein, triglycerides
    Time Frame
    six weeks
    Title
    Change in Glucose Level
    Description
    Fasting blood glucose
    Time Frame
    Six weeks
    Secondary Outcome Measure Information:
    Title
    Change in Weight (kg)
    Description
    Weight in kilograms
    Time Frame
    Six weeks
    Title
    Change in Waist Circumference (cm)
    Description
    Waist circumference in centimeters
    Time Frame
    six weeks
    Title
    Change in Hip Circumference (cm)
    Description
    Hip Circumference in centimeters
    Time Frame
    Six weeks
    Title
    Change in Waist:Hip (W:H ratio)
    Description
    Waist and hip measurement will be combined to report W:H ratio
    Time Frame
    Six weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Aged 20-59 years. Body mass index between 18.5 -35 kg/m2 Elevated cholesterol (total cholesterol >200 mg/dL or LDL cholesterol 130-190 mg/dL), and/or impaired fasting glucose (100-125mg/dL) Eat rice as a staple food at least twice per day Exclusion Criteria: Are pregnant or lactating Regularly consume pigmented rice (two meals per day in the past 4 weeks) Have cardiovascular disease (hypertension, stroke, ischemic heart disease, myocardial infarction, or congestive heart failure) or diabetes mellitus Take cholesterol or glucose-lowering medications Have elevated blood pressure (>130/80 mmHg) Have an illness that may influence lipid metabolism or metabolic rate (liver cirrhosis, pancreatitis, chronic kidney disease, hyperthyroidism, hypothyroidism) Take supplements that may influence lipids and glucose levels (including polyphenols) Are on a strict diet regimen (calorie-restricted or excluding food groups, examples: (Examples: Ketogenic diet, Intermittent fasting, No Rice diet) Have an active lifestyle (Ex. Goes to the gym daily, regularly (≥3 times a week) and perform vigorous activities such as lifting weights, swimming, cycling fast or uphill, or running, or athlete)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    DIANE S MENDOZA-SARMIENTO, MSc
    Phone
    +639088738336
    Email
    dsmendoza@ust.edu.ph
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alison M Hill, Ph.D
    Organizational Affiliation
    University of South Australia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Elizabeth H Arenas, PhD
    Organizational Affiliation
    University of Santo Tomas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Efficacy of Pigmented Rice on Reducing Cardiometabolic Risk Factors Among Filipino Adults

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