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

NCT ID: NCT05053347

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Elevated Blood Sugar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Flaxseed oil

Flaxseed oil capsule, 4.5 g/d (ALA 2.5 g/d)

Group Type EXPERIMENTAL

Flaxseed oil capsule

Intervention Type DIETARY_SUPPLEMENT

The participants were asked to take flaxseed oil capsule 4.5 g/d (ALA 2.5g/d). The intervention period is 24 weeks separated by a 12-week washout period. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.

Corn oil

Corn oil capsule, 4.5 g/d

Group Type PLACEBO_COMPARATOR

Corn oil capsule

Intervention Type DIETARY_SUPPLEMENT

The participants were asked to take corn oil capsule 4.5 g/d. The intervention period is 24 weeks separated by a 12-week washout period. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.

Interventions

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Flaxseed oil capsule

The participants were asked to take flaxseed oil capsule 4.5 g/d (ALA 2.5g/d). The intervention period is 24 weeks separated by a 12-week washout period. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.

Intervention Type DIETARY_SUPPLEMENT

Corn oil capsule

The participants were asked to take corn oil capsule 4.5 g/d. The intervention period is 24 weeks separated by a 12-week washout period. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Fasting blood glucose 6.1-8.4mmol /L;
* HbA1c 5.7-7.0%;
* 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 metabolic disorders, malignancies, psychiatric conditions;
* undergoing insulin therapy, or antibiotic/probiotic use for more than three consecutive days in the last month.
* Daily cooking oil is flaxseed oil, rapeseed oil or other α -linolenic acid rich vegetable oil;
* Intake more than 20g walnuts per day or more than 100g fatty fish per week in the last month;
* Take nutritional supplements, such as fish oil capsules, perilla seed oil and flaxseed oil capsules, for nearly one month;
* Allergic to the content of intervention;
* Failure to eat the tested sample as prescribed and affect the efficacy or safety judgment.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Liegang Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sinopharm Dongfeng General Hospital

Shiyan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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JWY20210916

Identifier Type: -

Identifier Source: org_study_id

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