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

Sponsor
Huazhong University of Science and Technology (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05053347
Collaborator
(none)
128
Enrollment
2
Arms
10.3
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Flaxseed oil capsule
  • Dietary Supplement: Corn oil capsule
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status: a Double-blind Randomized Controlled Cross-over Trial
Anticipated Study Start Date :
Feb 20, 2022
Anticipated Primary Completion Date :
Oct 20, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Flaxseed oil

Flaxseed oil capsule, 5g/d(ALA2.5g/d)

Dietary Supplement: Flaxseed oil capsule
The participants were asked to take flaxseed oil capsule 5d/day(ALA 2.5g/d). The intervention period is about 6 months separated by a one-month washout period. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
Placebo Comparator: Corn oil

Corn oil capsule, 5g/d

Dietary Supplement: Corn oil capsule
The participants were asked to take corn oil capsule 5d/day. The intervention period is about 6 months separated by a one-month washout period. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.

Outcome Measures

Primary Outcome Measures

  1. changes of HbA1c [0 week，12th week, 20th week and 32th week in the intervention period]

    glycated hemoglobin

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Huazhong University of Science and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liegang Liu, Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT05053347
Other Study ID Numbers:
  • JWY20210916
First Posted:
Sep 22, 2021
Last Update Posted:
Jan 14, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hyperglycemia

Study Results

No Results Posted as of Jan 14, 2022