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

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06092632
• Other study ID #: USantoTomas
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 13, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: October 2023
• Source: University of Santo Tomas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: November 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 59 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dyslipidemias
• Hyperglycaemia (Non Diabetic)
• Hyperglycemia
• Overweight
• Overweight or Obesity

Intervention

Other:
• Pigmented rice
Cooked black rice
• White Rice
Cooked white rice

Locations

Country	Name	City	State
Philippines	University of Santo Tomas	Manila	Metro Manila

Sponsors (1)

Lead Sponsor	Collaborator
University of Santo Tomas

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Lipid Levels	Total cholesterol, Low-density lipoprotein, high-density lipoprotein, triglycerides	six weeks
Primary	Change in Glucose Level	Fasting blood glucose	Six weeks
Secondary	Change in Weight (kg)	Weight in kilograms	Six weeks
Secondary	Change in Waist Circumference (cm)	Waist circumference in centimeters	six weeks
Secondary	Change in Hip Circumference (cm)	Hip Circumference in centimeters	Six weeks
Secondary	Change in Waist:Hip (W:H ratio)	Waist and hip measurement will be combined to report W:H ratio	Six weeks