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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flaxseed oil | Experimental | Flaxseed oil capsule, 4.5 g/d (ALA 2.5 g/d) |
|
| Corn oil | Placebo Comparator | Corn oil capsule, 4.5 g/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinopharm Dongfeng General Hospital | Shiyan | Hubei | 442000 | China |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008043 | Linseed Oil |
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D005224 | Fats, Unsaturated |
| D005223 | Fats |
| D008055 | Lipids |
| D010938 | Plant Oils |
| D009821 |
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|
| 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. |
|
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 |
| Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |