The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status
- Conditions
- Elevated Blood Sugar
- Registration Number
- NCT05053347
- Lead Sponsor
- Huazhong University of Science and Technology
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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 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.
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
Trial Locations
- Locations (1)
Sinopharm Dongfeng General Hospital
🇨🇳Shiyan, Hubei, China
Sinopharm Dongfeng General Hospital🇨🇳Shiyan, Hubei, China