Type 2 Diabetes MellitusNCT06061510
Fish Oil-derived Omega-3 Fatty Acids on Gut Microbiota and Lipid Metabolome in Type 2 Diabetes Mellitus
A study testing omega-3 polyunsaturated fatty acids and corn oil in people with Type 2 Diabetes Mellitus and Lipid Metabolism Disorder, run by Southeast University, China at 1 site in China.
Trial summary
The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Lipid Metabolism Disorder, Fatty Acid Metabolism Disorder
- What is being tested?
- omega-3 polyunsaturated fatty acids and corn oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2019to 31 Jan 2020
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes have been diagnosed;
- Male or female aged 18-70 years;
- After listening to the project presentation, voluntarily participate in the study and sign an informed consent form.
Who cannot join
- Pregnant or lactating women;
- Poorly controlled diabetes, i.e. HbA1c>9%；
- Have taken omega-3 PUFAs-related supplements in the past six months；
- Taking lipid-lowering drugs or other drugs that affect blood lipid metabolism；
- Patients with severe diabetic complications, severe hypertension, combined with
- diseases of the heart, brain, liver, kidney, thyroid and hematopoietic system, psychosis；
Show all 9Show fewer
- Patients with severe immune system disorders；
- Have special diets: vegetarians, weight managers, ketogenic test takers, etc；
- The attending physician deems the participant unsuitable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fish Oil-derived Omega-3 Fatty Acids on Gut Microbiota and Lipid Metabolome in Type 2 Diabetes Mellitus: a Randomized, Double-blind, Placebo-Controlled Clinical Trial
The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics.
Read the detailed description
The pathogenesis of diabetes is associated with perturbations in lipid metabolism and intestinal flora. Nevertheless, the precise impact of Omega-3 polyunsaturated fatty acids (Omega-3 PUFAs) on key lipid metabolites, intestinal microorganisms, and fungi linked to type 2 diabetes remains indeterminate. The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics. The investigators randomly allocated 110 eligible participants into either the fish oil intervention group or the placebo control group for a 3-month double-blind randomized intervention trial. Bacterial 16S rDNA, fungal diversity analysis of Internally Transcribed Spacer sequences (ITS) and untargeted lipidomics were used to investigate the effects of Omega-3 PUFAs on intestinal microbiota and serum lipid metabolites.
- Being tested
- omega-3 polyunsaturated fatty acids, corn oil
- Keywords
- Omega-3 Fatty Acids, Gut Microbiota, lipid Metabolome, glycerophospholipid, Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 polyunsaturated fatty acidsDietary supplement
Participants in the intervention group took fish oil capsules, 6 capsules per day, divided into two doses in the morning and two doses in the evening.
corn oilDietary supplement
Participants in the placebo group took corn oil capsules, 6 capsules per day, divided into two doses in the morning and two doses in the evening.
| Study group | Role | What they receive |
|---|---|---|
| fish oil group | Experimental | Fish oil supplement capsules contained omega-3 polyunsaturated fatty acids supplied by Royal DSM Group, the Netherlands. Each 100 grams of fish oil capsules contains mainly 36.86 grams of EPA, 17.47 grams of DHA and other types of fatty acids. Receives: Dietary Supplement: omega-3 polyunsaturated fatty acids |
| The placebo group | Placebo comparator | The placebo for fish oil contained corn oil (Each 100 grams of corn oil contained 45.64 grams of linoleic acid, 25.62 grams of oleic acid, 17.0 grams of palmitic acid, and other fatty acids). Receives: Dietary Supplement: corn oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Serum triglycerides
physiological parameter
Measured: 12 weeks
Concentration of total cholesterol
physiological parameter
Measured: 12 weeks
Concentration of low-density lipoprotein cholesterol
physiological parameter
Measured: 12 weeks
Concentration of high-density lipoprotein cholesterol
physiological parameter
Measured: 12 weeks
weight in kilograms
physiological parameter
Measured: 12 weeks
height in meters
physiological parameter
Measured: 12 weeks
body mass index (BMI)
BMI=weight(kg)/height^2(m)
Measured: 12 weeks
waist circumference
physiological parameter
Measured: 12 weeks
hip measurement
physiological parameter
Measured: 12 weeks
Systolic blood pressure
physiological parameter
Measured: 12 weeks
Diastolic blood pressure
physiological parameter
Measured: 12 weeks
Secondary outcomes (3)
Number of Participants who take drugs
This indicator refers to the number of participants taking medication.
Measured: 12 weeks
Incidence of diabetes complications
This indicator refers to the proportion of participants experiencing complications from diabetes.
Measured: 12 weeks
Rate of smoking among participants
This indicator refers to the proportion of participants who smoke.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start8 Jun 2019
- Primary completion29 Aug 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was a randomised, double-blind trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-yue Xia, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061510
- Sponsor's protocol ID
- NO. 2019710-6
- Status last verified
- Nov 2023
- First submitted
- 18 Sep 2023
- Last updated
- 27 Nov 2023
- 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 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Oil-derived Omega-3 Fatty Acids on Gut Microbiota and Lipid Metabolome in Type 2 Diabetes Mellitus: a Randomized, Double-blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06061510
- Acronym / sponsor ID
- NO. 2019710-6
- Keywords
- Omega-3 Fatty Acids, Gut Microbiota, lipid Metabolome, glycerophospholipid, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University
- Study start
- 8 Jun 2019 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 29 Sep 2023 (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 objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics.
Detailed description
The pathogenesis of diabetes is associated with perturbations in lipid metabolism and intestinal flora. Nevertheless, the precise impact of Omega-3 polyunsaturated fatty acids (Omega-3 PUFAs) on key lipid metabolites, intestinal microorganisms, and fungi linked to type 2 diabetes remains indeterminate. The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics. The investigators randomly allocated 110 eligible participants into either the fish oil intervention group or the placebo control group for a 3-month double-blind randomized intervention trial. Bacterial 16S rDNA, fungal diversity analysis of Internally Transcribed Spacer sequences (ITS) and untargeted lipidomics were used to investigate the effects of Omega-3 PUFAs on intestinal microbiota and serum lipid metabolites.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study was a randomised, double-blind trial.
| Arm | Type | Receives |
|---|---|---|
| fish oil group | Experimental | Dietary Supplement: omega-3 polyunsaturated fatty acidsFish oil supplement capsules contained omega-3 polyunsaturated fatty acids supplied by Royal DSM Group, the Netherlands. Each 100 grams of fish oil capsules contains mainly 36.86 grams of EPA, 17.47 grams of DHA and other types of fatty acids. |
| The placebo group | Placebo comparator | Dietary Supplement: corn oilThe placebo for fish oil contained corn oil (Each 100 grams of corn oil contained 45.64 grams of linoleic acid, 25.62 grams of oleic acid, 17.0 grams of palmitic acid, and other fatty acids). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes have been diagnosed;
- Male or female aged 18-70 years;
- After listening to the project presentation, voluntarily participate in the study and sign an informed consent form.
Key exclusion criteria (9 listed)
- Pregnant or lactating women;
- Poorly controlled diabetes, i.e. HbA1c>9%；
- Have taken omega-3 PUFAs-related supplements in the past six months；
- Taking lipid-lowering drugs or other drugs that affect blood lipid metabolism；
- Patients with severe diabetic complications, severe hypertension, combined with
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 |
|---|---|---|
| omega-3 polyunsaturated fatty acidsParticipants in the intervention group took fish oil capsules, 6 capsules per day, divided into two doses in the morning and two doses in the evening. | Dietary supplement | fish oil group |
| corn oilParticipants in the placebo group took corn oil capsules, 6 capsules per day, divided into two doses in the morning and two doses in the evening. | Dietary supplement | The placebo group |
Primary outcome
Concentration of Serum triglycerides
Time frame: 12 weeks
physiological parameter
Concentration of total cholesterol
Time frame: 12 weeks
physiological parameter
Concentration of low-density lipoprotein cholesterol
Time frame: 12 weeks
physiological parameter
Concentration of high-density lipoprotein cholesterol
Time frame: 12 weeks
physiological parameter
weight in kilograms
Time frame: 12 weeks
physiological parameter
height in meters
Time frame: 12 weeks
physiological parameter
body mass index (BMI)
Time frame: 12 weeks
BMI=weight(kg)/height^2(m)
waist circumference
Time frame: 12 weeks
physiological parameter
hip measurement
Time frame: 12 weeks
physiological parameter
Systolic blood pressure
Time frame: 12 weeks
physiological parameter
Diastolic blood pressure
Time frame: 12 weeks
physiological parameter
3 secondary outcomes
Number of Participants who take drugs
Time frame: 12 weeks
Incidence of diabetes complications
Time frame: 12 weeks
Rate of smoking among participants
Time frame: 12 weeks
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 27 Nov 2023.
- Individual participant dataSharing planned: No
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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 omega-3 polyunsaturated fatty acids and corn oil in people with Type 2 Diabetes Mellitus and Lipid Metabolism Disorder, run by Southeast University, China 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 9 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 27 Nov 2023. 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?
Concentration of Serum triglycerides (time frame: 12 weeks). The study lists 11 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 27 Nov 2023.