DyslipidemiasNCT06092632
Efficacy of Pigmented Rice on Reducing Cardiometabolic Risk Factors Among Filipino Adults
A study testing Pigmented rice and White Rice in people with Dyslipidemias and Overweight or Obesity, run by University of Santo Tomas at 1 site in Philippines.
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. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Overweight or Obesity, Hyperglycaemia (Non Diabetic)
- What is being tested?
- Pigmented rice and White Rice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePhilippines
- Study dates
- 13 Oct 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Philippines1 site
University of Santo Tomas
Manila, National Capital Region, 1015
About this study
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.
Read the 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.
- Being tested
- Pigmented rice, White Rice
- Keywords
- pigmented rice, dyslipidemia, hyperglycemia
- Medical subject headings
- Dyslipidemias, Overweight, Obesity, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pigmented riceOther
Also called Black Rice
Cooked black rice
White RiceOther
Cooked white rice
| Study group | Role | What they receive |
|---|---|---|
| Pigmented Rice | Experimental | Cooked black pigmented rice will be consumed for six weeks (twice per day) Receives: Other: Pigmented rice |
| White Rice | Placebo comparator | Cooked white rice will be consumed by the control group for six weeks (twice per day) Receives: Other: White Rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lipid Levels
Total cholesterol, Low-density lipoprotein, high-density lipoprotein, triglycerides
Measured: six weeks
Change in Glucose Level
Fasting blood glucose
Measured: Six weeks
Secondary outcomes (4)
Change in Weight (kg)
Weight in kilograms
Measured: Six weeks
Change in Waist Circumference (cm)
Waist circumference in centimeters
Measured: six weeks
Change in Hip Circumference (cm)
Hip Circumference in centimeters
Measured: Six weeks
Change in Waist:Hip (W:H ratio)
Waist and hip measurement will be combined to report W:H ratio
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start13 Oct 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santo Tomas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diane S. Mendoza-Sarmiento, University of Santo Tomas
- Investigators
- Alison M Hill, Ph.D, Principal investigator, University of South AustraliaElizabeth H Arenas, PhD, Principal investigator, University of Santo Tomas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092632
- Sponsor's protocol ID
- USantoTomas
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pigmented Rice on Reducing Cardiometabolic Risk Factors Among Filipino Adults
- ClinicalTrials.gov ID
- NCT06092632
- Acronym / sponsor ID
- USantoTomas
- Keywords
- pigmented rice, dyslipidemia, hyperglycemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Santo TomasUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pigmented Rice | Experimental | Other: Pigmented riceCooked black pigmented rice will be consumed for six weeks (twice per day) |
| White Rice | Placebo comparator | Other: White RiceCooked white rice will be consumed by the control group for six weeks (twice per day) |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pigmented riceAlso: Black RiceCooked black rice | Other | Pigmented Rice |
| White RiceCooked white rice | Other | White Rice |
Primary outcome
Change in Lipid Levels
Time frame: six weeks
Total cholesterol, Low-density lipoprotein, high-density lipoprotein, triglycerides
Change in Glucose Level
Time frame: Six weeks
Fasting blood glucose
4 secondary outcomes
Change in Weight (kg)
Time frame: Six weeks
Change in Waist Circumference (cm)
Time frame: six weeks
Change in Hip Circumference (cm)
Time frame: Six weeks
Change in Waist:Hip (W:H ratio)
Time frame: Six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison M Hill, Ph.D principal investigator
University of South Australia
Elizabeth H Arenas, PhD principal investigator
University of Santo Tomas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pigmented rice and White Rice in people with Dyslipidemias and Overweight or Obesity, run by University of Santo Tomas at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lipid Levels (time frame: six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.