Elevated Blood SugarNCT05053347
The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status
A study testing Flaxseed oil capsule and Corn oil capsule in people with Elevated Blood Sugar, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Elevated Blood Sugar
- What is being tested?
- Flaxseed oil capsule and Corn oil capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status: a Double-blind Randomized Controlled Cross-over Trial
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.
- Conditions
- Elevated Blood Sugar
- Being tested
- Flaxseed oil capsule, Corn oil capsule
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flaxseed oil capsuleDietary 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.
Corn oil capsuleDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Flaxseed oil | Experimental | Flaxseed oil capsule, 4.5 g/d (ALA 2.5 g/d) Receives: Dietary Supplement: Flaxseed oil capsule |
| Corn oil | Placebo comparator | Corn oil capsule, 4.5 g/d Receives: Dietary Supplement: Corn oil capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of fasting blood glucose
fasting blood glucose
Measured: 0 week, 12th week, 24th week and 36th week in the intervention period
changes of glycated hemoglobin (HbA1c)
glycated hemoglobin (HbA1c)
Measured: 0 week, 12th week, 24th week and 36th week in the intervention period
Secondary outcomes (6)
changes of circulating fatty acids
plasma and erythrocyte fatty acid profiles
Measured: 0 week, 12th week, 24th week and 36th week in the intervention period
changes in the relative abundance of gut microbiota
Evaluate alterations in the relative abundance of gut microbiota across taxonomic levels by 16S rRNA sequencing.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 week, 12th week, 24th week and 36th week in the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Jul 2022
- Primary completion30 Jun 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood SugarStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liegang Liu, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053347
- Sponsor's protocol ID
- JWY20210916
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2021
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status: a Double-blind Randomized Controlled Cross-over Trial
- ClinicalTrials.gov ID
- NCT05053347
- Acronym / sponsor ID
- JWY20210916
- Conditions
- Elevated Blood Sugar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flaxseed oil | Experimental | Dietary Supplement: Flaxseed oil capsuleFlaxseed oil capsule, 4.5 g/d (ALA 2.5 g/d) |
| Corn oil | Placebo comparator | Dietary Supplement: Corn oil capsuleCorn oil capsule, 4.5 g/d |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flaxseed oil capsuleThe 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 supplement | Flaxseed oil |
| Corn oil capsuleThe 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. | Dietary supplement | Corn oil |
Primary outcome
changes of fasting blood glucose
Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period
fasting blood glucose
changes of glycated hemoglobin (HbA1c)
Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period
glycated hemoglobin (HbA1c)
6 secondary outcomes
changes of circulating fatty acids
Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period
changes in the relative abundance of gut microbiota
Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period
changes of fecal short-chain fatty acid
Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period
nutrient-gene interaction on circulating n-3 PUFAs
Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period
nutrient-gene interaction on fasting blood glucose
Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period
nutrient-gene interaction on HbA1c
Time frame: 0 week, 12th week, 24th week and 36th week in the intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Elevated Blood Sugar
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flaxseed oil capsule and Corn oil capsule in people with Elevated Blood Sugar, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of fasting blood glucose (time frame: 0 week, 12th week, 24th week and 36th week in the intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.