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

Sponsor

University of Santo Tomas (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06092632

Collaborator

(none)

Enrollment

Arms

13.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias Overweight or Obesity Hyperglycaemia (Non Diabetic)	Other: Pigmented rice Other: White Rice	N/A

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

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 13, 2023

Anticipated Primary Completion Date :

Aug 30, 2024

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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
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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Change in Lipid Levels [six weeks]
Total cholesterol, Low-density lipoprotein, high-density lipoprotein, triglycerides
Change in Glucose Level [Six weeks]
Fasting blood glucose

Secondary Outcome Measures

Change in Weight (kg) [Six weeks]
Weight in kilograms
Change in Waist Circumference (cm) [six weeks]
Waist circumference in centimeters
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 59 Years

Sexes Eligible for Study:

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)