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

University of Santo Tomas

Status: Invitation-only

Conditions: Overweight or Obesity; Dyslipidemias; Hyperglycaemia (Non Diabetic)

Treatments: Other: Pigmented rice; Other: White Rice

Study type: Interventional

Funder types: Other

Identifiers

NCT06092632

USantoTomas

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Pigmented Rice

Experimental group

Description:

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

Treatment:

Other: Pigmented rice

White Rice

Placebo Comparator group

Description:

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

Treatment:

Other: White Rice