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CompletedNCT02407522IDSBRMSUpdated Apr 3, 2015

The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome

A Phase 2/3 interventional study of Black rice and follow-up in Metabolic Syndrome X, sponsored by Sun Yat-sen University. Completed. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-04-03.

Sponsored by Sun Yat-sen University · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to thoroughly investigate how the interaction between black rice and human gut microbiota affects metabolic diseases, this study will recruit patients with Metabolic Syndrome (MS) and provide them with dietary supplementation of black rice (50 g/day) for 3 months to observe its effect on the development of MS. The focuses of this project are to elucidate how black rice consumption affects the composition and metabolism of intestinal bacteria as well as the development of MS, and to further analyze whether the changes in intestinal bacteria are associated with the changes in MS improvements.

02

Conditions studied

  • Metabolic Syndrome X

Keywords

  • Metabolic Syndrome
  • black rice
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 101 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • individuals meeting at least 3 of the following 5 criteria will be chosen:
  • abdominal obesity: using the waist standard for Asians: waist≥90 for male and ≥80 for female
  • high blood sugar: fasting plasma glucose≥5.6mmol/L (100mg/d L) or individuals diagnosed with diabetes and being treated
  • hypertension: systolic blood pressure≥130 mm Hg or diastolic blood pressure≥85 mm Hg or individuals diagnosed with hypertension and being treated
  • dyslipidemia: fasting total triglycerides≥1.70 mmol/L(150 mg/d L) or individuals undergoing lipid-lowering therapy
  • fasting plasma high-density lipoprotein cholesterol\<1.03mmol/L (40mg/dL) for male or \<1.3mmol/L (50mg/dL) for female.

Exclusion criteria

Exclusion Criteria:

  • having current or former cardiovascular disease, including coronary heart disease (e.g., angina pectoris, myocardial infarction, coronary revascularization, abnormal Q waves in ECG), stroke (e.g., congestive, hemorrhagic, or transient ischemic stroke), and intermittent claudication caused by peripheral arterial diseases;
  • severe clinical conditions that may compromise patients' participation in experiments, e.g., digestive diseases leading to inability to maintain black rice uptake, patients receiving parenteral nutrition supply, malignancies in progress, and mental illness;
  • immunodeficiency disease or AIDS, chronic inflammation conditions
  • drug abuse or alcoholism (>80g/d).
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
101 participants (actual)

Study arms

  • Experimental
    black rice group

    Each subject in the experimental group will be provided with black rice (50 g/day).According to the clinical requirements, no specific rules are needed for other treatments of the two groups.

    Dietary Supplement: Black rice

  • Placebo comparator
    white rice group

    individuals in the control group will be subjected to follow-up. According to the clinical requirements, no specific rules are needed for other treatments of the two groups.

    Other: follow-up

Interventions

  • Dietary supplementBlack rice

    They asked to keep their normal life style during intervention

  • Otherfollow-up

    They asked not to consume any black rice or excess amount of food rich in anthocyanin compared to their normal life style, such as grapes, blueberry, red wine, black bean during intervention.

06

What researchers measure

Primary outcomes

  1. reversal rate of metabolic syndrome

    Numerator is number of people is metabolic syndrome at baseline but not after intervention. The denominator is the overall number of people in the group

    Time frame: 3 months

Secondary outcomes

  1. proportion of Bacteroides

    PCR analysis the RNA of Bacteroides in faeces

    Time frame: 3months

  2. proportion of Bifidobacterium

    PCR analysis the RNA of Bacteroides in faeces

    Time frame: 3months

Other outcomes

  1. changes in fasting blood-glucose

    (after intervention - baseline)/baseline×100%

    Time frame: 3 months

  2. changes in fasting total triglyceride

    (after intervention - baseline)/baseline×100%

    Time frame: 3 months

  3. changes in fasting HDL-c

    (after intervention - baseline)/baseline×100%

    Time frame: 3 months

  4. changes in fasting LDL-c

    (after intervention - baseline)/baseline×100%

    Time frame: 3 months

  5. changes in fasting waistline

    (after intervention - baseline)/baseline×100%

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02407522
Lead sponsor
Sun Yat-sen University
Responsible party
zhangpeiwen (PhD candidate, Sun Yat-sen University) — Principal investigator
First posted
Apr 3, 2015
Start date
Jun 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Apr 3, 2015

Study contacts

Ling wenhua, profess
study director · Sun Yat-sen University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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