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

NCT ID: NCT06092632

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-13
• Study Completion Date: 2024-11-30

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.

Conditions

Dyslipidemias; Overweight or Obesity; Hyperglycaemia (Non Diabetic)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Pigmented Rice

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

Group Type: EXPERIMENTAL

Pigmented rice

Intervention Type: OTHER

Cooked black rice

White Rice

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

Group Type: PLACEBO_COMPARATOR

White Rice

Intervention Type: OTHER

Cooked white rice

Interventions

Pigmented rice

Cooked black rice

Intervention Type: OTHER

White Rice

Cooked white rice

Intervention Type: OTHER

Other Intervention Names

Black Rice

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Santo Tomas

OTHER

Sponsor Role: lead

Responsible Party

Diane S. Mendoza-Sarmiento

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alison M Hill, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of South Australia

Elizabeth H Arenas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Santo Tomas

Locations

University of Santo Tomas

Manila, National Capital Region, Philippines

Countries

Philippines

Other Identifiers

USantoTomas

Identifier Type: -

Identifier Source: org_study_id