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

Study Overview
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Brief Summary
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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.

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

Conditions
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Elevated Blood Sugar

Intervention / Treatment
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* Dietary Supplement: Flaxseed oil capsule
* Dietary Supplement: Corn oil capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flaxseed oil<br>Flaxseed oil capsule, 5g/d(ALA2.5g/d) | Dietary Supplement: Flaxseed oil capsule<br>* 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.<br>|
| Placebo Comparator: Corn oil<br>Corn oil capsule, 5g/d | Dietary Supplement: Corn oil capsule<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of HbA1c | glycated hemoglobin | 0 week，12th week, 20th week and 32th week in the intervention period |