Skip to main content
OpenTrials
Completed

NCT Number: NCT05053347

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Elevated Blood Sugar Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sinopharm Dongfeng General Hospital

Shiyan, Hubei, 442000, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Flaxseed oil capsule

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 capsule

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.

Primary outcomes

  1. changes of fasting blood glucose

    Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period

    fasting blood glucose

  2. changes of glycated hemoglobin (HbA1c)

    Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period

    glycated hemoglobin (HbA1c)

Secondary outcomes

  1. changes of circulating fatty acids

    Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period

    plasma and erythrocyte fatty acid profiles

  2. changes in the relative abundance of gut microbiota

    Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period

    Evaluate alterations in the relative abundance of gut microbiota across taxonomic levels by 16S rRNA sequencing.

  3. changes of fecal short-chain fatty acid

    Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period

    fecal short-chain fatty acid

  4. nutrient-gene interaction on circulating n-3 PUFAs

    Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period

    The impact of genetic diversity in FADS and ELOVL gene clusters on changes in circulating n-3 PUFAs after ALA intervention.

  5. nutrient-gene interaction on fasting blood glucose

    Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period

    The impact of genetic diversity of diabetes-associated genes on changes in fasting blood glucose after ALA intervention.

  6. nutrient-gene interaction on HbA1c

    Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period

    The impact of genetic diversity of diabetes-associated genes on changes in HbA1c after ALA intervention.

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status: a Double-blind Randomized Controlled Cross-over Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 22, 2021
Registry last updated
Oct 1, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.