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

H

Huazhong University of Science and Technology

Status

Completed

Conditions

Elevated Blood Sugar

Treatments

Dietary Supplement: Flaxseed oil capsule
Dietary Supplement: Corn oil capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT05053347
JWY20210916

Details and patient eligibility

About

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.

Enrollment

94 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

94 participants in 2 patient groups, including a placebo group

Flaxseed oil
Experimental group
Description:
Flaxseed oil capsule, 4.5 g/d (ALA 2.5 g/d)
Treatment:
Dietary Supplement: Flaxseed oil capsule
Corn oil
Placebo Comparator group
Description:
Corn oil capsule, 4.5 g/d
Treatment:
Dietary Supplement: Corn oil capsule

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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