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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Dyslipidemias; Overweight or Obesity; Hyperglycaemia (Non Diabetic)
• Intervention / Treatment: Other: Pigmented rice; Other: White Rice

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Metro Manila
    • Manila, Metro Manila, Philippines, 1015
      • University of Santo Tomas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Santo Tomas
• Investigators: Principal Investigator: Alison M Hill, Ph.D, University of South Australia; Principal Investigator: Elizabeth H Arenas, PhD, University of Santo Tomas

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 14, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: hyperglycemia; dyslipidemia; pigmented rice
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Lipid Metabolism Disorders; Hyperglycemia; Dyslipidemias; Overweight
• Other Study ID Numbers: USantoTomas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No