NCT06092632

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 13, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 10, 2023

Last Update Submit

October 26, 2023

Conditions

DyslipidemiasOverweight or ObesityHyperglycaemia (Non Diabetic)

Keywords

pigmented ricedyslipidemiahyperglycemia

Outcome Measures

Primary Outcomes (2)

  • Change in Lipid Levels

    Total cholesterol, Low-density lipoprotein, high-density lipoprotein, triglycerides

    six weeks

  • Change in Glucose Level

    Fasting blood glucose

    Six weeks

Secondary Outcomes (4)

  • Change in Weight (kg)

    Six weeks

  • Change in Waist Circumference (cm)

    six weeks

  • Change in Hip Circumference (cm)

    Six weeks

  • Change in Waist:Hip (W:H ratio)

    Six weeks

Study Arms (2)

Pigmented Rice

EXPERIMENTAL

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

Other: Pigmented rice

White Rice

PLACEBO COMPARATOR

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

Other: White Rice

Interventions

Pigmented riceOTHER

Cooked black rice

Also known as: Black Rice
Pigmented Rice
White RiceOTHER

Cooked white rice

White Rice

Eligibility Criteria

Age20 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Santo Tomas

Manila, National Capital Region, 1015, Philippines

Location

MeSH Terms

Conditions

DyslipidemiasOverweightObesityHyperglycemia

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism Disorders

Study Officials

  • Alison M Hill, Ph.D

    University of South Australia

    PRINCIPAL INVESTIGATOR

  • Elizabeth H Arenas, PhD

    University of Santo Tomas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 23, 2023

Study Start

October 13, 2023

Primary Completion

August 30, 2024

Study Completion

November 30, 2024

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

PH(1)