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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dyslipidemias, Overweight or Obesity, Hyperglycaemia (Non Diabetic)

Intervention / Treatment
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* Other: Pigmented rice
* Other: White Rice


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pigmented Rice<br>Cooked black pigmented rice will be consumed for six weeks (twice per day) | Other: Pigmented rice<br>* Cooked black rice<br>* Other names: Black Rice;|
| Placebo Comparator: White Rice<br>Cooked white rice will be consumed by the control group for six weeks (twice per day) | Other: White Rice<br>* Cooked white rice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lipid Levels | Total cholesterol, Low-density lipoprotein, high-density lipoprotein, triglycerides | six weeks | 
| Change in Glucose Level | Fasting blood glucose | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight (kg) | Weight in kilograms | Six weeks | 
| Change in Waist Circumference (cm) | Waist circumference in centimeters | six weeks | 
| Change in Hip Circumference (cm) | Hip Circumference in centimeters | Six weeks | 
| Change in Waist:Hip (W:H ratio) | Waist and hip measurement will be combined to report W:H ratio | Six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pigmented rice, dyslipidemia, hyperglycemia