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The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status

Primary Purpose

Elevated Blood Sugar

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Flaxseed oil capsule
Corn oil capsule
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elevated Blood Sugar

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fasting blood glucose 6.1-8.4mmol /L;
  • HBA1c 5.7-7.0%;
  • OGTT 2h or postprandial blood glucose 7.8-11.1 mmol/L;
  • Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well.

Exclusion Criteria:

  • Under 30 years old or over 75 years old;
  • Suffering from severe obesity, thyroid disease, or other serious diseases, such as mental illness;
  • Take nutritional supplements, such as fish oil capsules, Perilla seed oil and flaxseed oil capsules, for nearly one month;
  • Intake more than 20g walnuts per day or more than 100g fatty fish per week in the last month;
  • Daily cooking oil is linseed oil or rapeseed oil and other α -linolenic acid rich vegetable oil;
  • Have been diagnosed with type 2 diabetes and are currently receiving insulin injection;
  • Allergic to the content of intervention;
  • Failure to eat the tested sample as prescribed and affect the efficacy or safety judgment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Flaxseed oil

    Corn oil

    Arm Description

    Flaxseed oil capsule, 5g/d(ALA2.5g/d)

    Corn oil capsule, 5g/d

    Outcomes

    Primary Outcome Measures

    changes of HbA1c
    glycated hemoglobin

    Secondary Outcome Measures

    Full Information

    First Posted
    September 16, 2021
    Last Updated
    December 28, 2021
    Sponsor
    Huazhong University of Science and Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05053347
    Brief Title
    The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status
    Official Title
    The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status: a Double-blind Randomized Controlled Cross-over Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 20, 2022 (Anticipated)
    Primary Completion Date
    October 20, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Huazhong University of Science and Technology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The findings of previous experiments suggested that alpha linolenic acid (ALA) has been linked to anti-hyperglycemic, and reducing the risk of diabetes.This is a randomized double-blind cross-over trial, aims to study the effect of ALA on glycemic status and human metabolism. Firstly, the investigators will investigate the efficacy of ALA on improving the indexes of glucose metabolism. Secondly, next generation sequencing (NGS), ultra-high performance liquid chromatography-tandem mass spectrometric (UPLC-MS/MS) and gas chromatography-mass spectrometry detection will be conducted to explore the role of ALA on gut microbiota as well as metabolites. Thirdly, single nucleotide polymorphism will be genotyped by Time-of-flight mass spectrometry to find the gene-environment interaction effect.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Elevated Blood Sugar

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    128 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Flaxseed oil
    Arm Type
    Experimental
    Arm Description
    Flaxseed oil capsule, 5g/d(ALA2.5g/d)
    Arm Title
    Corn oil
    Arm Type
    Placebo Comparator
    Arm Description
    Corn oil capsule, 5g/d
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Flaxseed oil capsule
    Intervention Description
    The participants were asked to take flaxseed oil capsule 5d/day(ALA 2.5g/d). The intervention period is about 6 months separated by a one-month washout period. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Corn oil capsule
    Intervention Description
    The participants were asked to take corn oil capsule 5d/day. The intervention period is about 6 months separated by a one-month washout period. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
    Primary Outcome Measure Information:
    Title
    changes of HbA1c
    Description
    glycated hemoglobin
    Time Frame
    0 week，12th week, 20th week and 32th week in the intervention period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Fasting blood glucose 6.1-8.4mmol /L; HBA1c 5.7-7.0%; OGTT 2h or postprandial blood glucose 7.8-11.1 mmol/L; Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well. Exclusion Criteria: Under 30 years old or over 75 years old; Suffering from severe obesity, thyroid disease, or other serious diseases, such as mental illness; Take nutritional supplements, such as fish oil capsules, Perilla seed oil and flaxseed oil capsules, for nearly one month; Intake more than 20g walnuts per day or more than 100g fatty fish per week in the last month; Daily cooking oil is linseed oil or rapeseed oil and other α -linolenic acid rich vegetable oil; Have been diagnosed with type 2 diabetes and are currently receiving insulin injection; Allergic to the content of intervention; Failure to eat the tested sample as prescribed and affect the efficacy or safety judgment.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status

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