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

Not Applicable

• Conditions: Elevated Blood Sugar
• Interventions: Dietary Supplement: Flaxseed oil capsule; Dietary Supplement: Corn oil capsule

• Registration Number: NCT05053347
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-22
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2022-01-14
• Study Start: 2022-02-20
• Primary Completion: 2022-10-20
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Flaxseed oil	Flaxseed oil capsule	Flaxseed oil capsule, 5g/d(ALA2.5g/d)
Corn oil	Corn oil capsule	Corn oil capsule, 5g/d

Primary Outcome Measures

Name	Time	Method
changes of HbA1c	0 week，12th week, 20th week and 32th week in the intervention period	glycated hemoglobin