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

Not Applicable
Conditions
Overweight or Obesity
Dyslipidemias
Hyperglycaemia (Non Diabetic)
Interventions
Other: White Rice
Other: Pigmented rice
Registration Number
NCT06092632
Lead Sponsor
University of Santo Tomas
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.

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
60
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
White RiceWhite RiceCooked white rice will be consumed by the control group for six weeks (twice per day)
Pigmented RicePigmented riceCooked black pigmented rice will be consumed for six weeks (twice per day)
Primary Outcome Measures
NameTimeMethod
Change in Lipid Levelssix weeks

Total cholesterol, Low-density lipoprotein, high-density lipoprotein, triglycerides

Change in Glucose LevelSix weeks

Fasting blood glucose

Secondary Outcome Measures
NameTimeMethod
Change in Waist Circumference (cm)six weeks

Waist circumference in centimeters

Change in Weight (kg)Six weeks

Weight in kilograms

Change in Hip Circumference (cm)Six weeks

Hip Circumference in centimeters

Change in Waist:Hip (W:H ratio)Six weeks

Waist and hip measurement will be combined to report W:H ratio

Trial Locations

Locations (1)

University of Santo Tomas

🇵🇭

Manila, Metro Manila, Philippines

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