Clinical trial NCT06092632: Efficacy of Pigmented Rice on Reducing Cardiometabolic Risk Factors Among Filipino Adults
Official title: Efficacy of Pigmented Rice on Reducing Cardiometabolic Risk Factors Among Filipino Adults
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dyslipidemias
Overweight or Obesity
Hyperglycaemia (Non Diabetic)
Keywords: pigmented rice
dyslipidemia
hyperglycemia
Lead sponsor: University of Santo Tomas
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Change in Lipid Levels
timeFrame: six weeks
measure: Change in Glucose Level
timeFrame: Six weeks
Secondary outcomes:
measure: Change in Weight (kg)
timeFrame: Six weeks
measure: Change in Waist Circumference (cm)
timeFrame: six weeks
measure: Change in Hip Circumference (cm)
timeFrame: Six weeks
measure: Change in Waist:Hip (W:H ratio)
timeFrame: Six weeks
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: University of Santo Tomas
state: Metro Manila
Study officials:
affiliation: University of South Australia
name: Alison M Hill, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Santo Tomas
name: Elizabeth H Arenas, PhD
role: PRINCIPAL_INVESTIGATOR
References: