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Completed

NCT Number: NCT02407522

The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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).

Treatment and study plan

Black rice

Dietary Supplement

They asked to keep their normal life style during intervention

Follow-up

Other

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.

Primary outcomes

  1. reversal rate of metabolic syndrome

    Time frame: 3 months

    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

Secondary outcomes

  1. proportion of Bacteroides

    Time frame: 3months

    PCR analysis the RNA of Bacteroides in faeces

  2. proportion of Bifidobacterium

    Time frame: 3months

    PCR analysis the RNA of Bacteroides in faeces

Other outcomes

  1. changes in fasting blood-glucose

    Time frame: 3 months

    (after intervention - baseline)/baseline×100%

  2. changes in fasting total triglyceride

    Time frame: 3 months

    (after intervention - baseline)/baseline×100%

  3. changes in fasting HDL-c

    Time frame: 3 months

    (after intervention - baseline)/baseline×100%

  4. changes in fasting LDL-c

    Time frame: 3 months

    (after intervention - baseline)/baseline×100%

  5. changes in fasting waistline

    Time frame: 3 months

    (after intervention - baseline)/baseline×100%

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome and Its Correlation With Metabolism of Gut Microbiota

Acronym: IDSBRMS

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 3, 2015
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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