Elevated Blood Sugar
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFlaxseed 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.
DIETARY_SUPPLEMENTCorn 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.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes of fasting blood glucose | 0 week, 12th week, 24th week and 36th week in the intervention period | fasting blood glucose |
| changes of glycated hemoglobin (HbA1c) | 0 week, 12th week, 24th week and 36th week in the intervention period | glycated hemoglobin (HbA1c) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes of circulating fatty acids | 0 week, 12th week, 24th week and 36th week in the intervention period | plasma and erythrocyte fatty acid profiles |
| nutrient-gene interaction on circulating n-3 PUFAs | 0 week, 12th week, 24th week and 36th week in the intervention period | The impact of genetic diversity in FADS and ELOVL gene clusters on changes in circulating n-3 PUFAs after ALA intervention. |
| changes in the relative abundance of gut microbiota | 0 week, 12th week, 24th week and 36th week in the intervention period | Evaluate alterations in the relative abundance of gut microbiota across taxonomic levels by 16S rRNA sequencing. |
| nutrient-gene interaction on HbA1c | 0 week, 12th week, 24th week and 36th week in the intervention period | The impact of genetic diversity of diabetes-associated genes on changes in HbA1c after ALA intervention. |
| nutrient-gene interaction on fasting blood glucose | 0 week, 12th week, 24th week and 36th week in the intervention period | The impact of genetic diversity of diabetes-associated genes on changes in fasting blood glucose after ALA intervention. |
| changes of fecal short-chain fatty acid | 0 week, 12th week, 24th week and 36th week in the intervention period | fecal short-chain fatty acid |
Countries
China
Outcome results
None listed