Efficacy of Pigmented Rice on Reducing Cardiometabolic Risk Factors Among Filipino Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in Lipid Levels
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
Change in Lipid Levels
Time Frame: six weeks
Total cholesterol, Low-density lipoprotein, high-density lipoprotein, triglycerides
Change in Glucose Level
Time Frame: Six weeks
Fasting blood glucose
Secondary Outcomes
- Change in Waist Circumference (cm)(six weeks)
- Change in Weight (kg)(Six weeks)
- Change in Hip Circumference (cm)(Six weeks)
- Change in Waist:Hip (W:H ratio)(Six weeks)
Investigators
Diane S. Mendoza-Sarmiento
Principal Investigator
University of Santo Tomas