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

NCT05053347 | Completed

• 1 other identifier: JWY20210916
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Elevated Blood Sugar

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• changes of circulating fatty acids

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

• changes in the relative abundance of gut microbiota

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

• changes of 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

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

• nutrient-gene interaction on fasting blood glucose

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

Study Arms (2)

Flaxseed oil

EXPERIMENTAL

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

Dietary Supplement: Flaxseed oil capsule

Corn oil

PLACEBO COMPARATOR

Corn oil capsule, 4.5 g/d

Dietary Supplement: Corn oil capsule

Interventions

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.

Flaxseed oil

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.

Corn oil

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Sinopharm Dongfeng General Hospital

Shiyan, Hubei, 442000, China

Location

MeSH Terms

Conditions

Hyperglycemia

Interventions

Linseed Oil; Corn Oil

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Dietary Fats, Unsaturated; Dietary Fats; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 22, 2021
• Study Start: July 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2024
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)