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

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

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.

Study Overview

• Status: Completed
• Conditions: Elevated Blood Sugar
• Intervention / Treatment: Dietary supplement: Flaxseed oil capsule; Dietary supplement: Corn oil capsule

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Shiyan, Hubei, China, 442000
      • Sinopharm Dongfeng General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flaxseed oil; Flaxseed oil capsule, 4.5 g/d (ALA 2.5 g/d)	Dietary supplement: 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.
Placebo Comparator: Corn oil; Corn oil capsule, 4.5 g/d	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of fasting blood glucose	fasting blood glucose	0 week, 12th week, 24th week and 36th week in the intervention period
changes of glycated hemoglobin (HbA1c)	glycated hemoglobin (HbA1c)	0 week, 12th week, 24th week and 36th week in the intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of circulating fatty acids	plasma and erythrocyte fatty acid profiles	0 week, 12th week, 24th week and 36th week in the intervention period
changes in the relative abundance of gut microbiota	Evaluate alterations in the relative abundance of gut microbiota across taxonomic levels by 16S rRNA sequencing.	0 week, 12th week, 24th week and 36th week in the intervention period
changes of fecal short-chain fatty acid	fecal short-chain fatty acid	0 week, 12th week, 24th week and 36th week in the intervention period
nutrient-gene interaction on circulating n-3 PUFAs	The impact of genetic diversity in FADS and ELOVL gene clusters on changes in circulating n-3 PUFAs after ALA intervention.	0 week, 12th week, 24th week and 36th week in the intervention period
nutrient-gene interaction on fasting blood glucose	The impact of genetic diversity of diabetes-associated genes on changes in fasting blood glucose after ALA intervention.	0 week, 12th week, 24th week and 36th week in the intervention period
nutrient-gene interaction on HbA1c	The impact of genetic diversity of diabetes-associated genes on changes in HbA1c after ALA intervention.	0 week, 12th week, 24th week and 36th week in the intervention period

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Hyperglycemia; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Preparations; Biological Products; Complex Mixtures; Plant Oils; Oils; Dietary Fats; Fats; Dietary Fats, Unsaturated; Fats, Unsaturated; Linseed Oil; Corn Oil
• Other Study ID Numbers: JWY20210916

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No