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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06061510
Other study ID # NO. 2019710-6
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 8, 2019
Est. completion date January 31, 2020

Study information

Verified date November 2023
Source Southeast University, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date January 31, 2020
Est. primary completion date August 29, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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; - Patients with severe immune system disorders; - Have special diets: vegetarians, weight managers, ketogenic test takers, etc; - The attending physician deems the participant unsuitable

Study Design


Intervention

Dietary Supplement:
omega-3 polyunsaturated fatty acids
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 oil
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.

Locations

Country Name City State
China Southeast university Nanjing Jiangsu

Sponsors (2)

Lead Sponsor Collaborator
Southeast University, China The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of Serum triglycerides physiological parameter 12 weeks
Primary Concentration of total cholesterol physiological parameter 12 weeks
Primary Concentration of low-density lipoprotein cholesterol physiological parameter 12 weeks
Primary Concentration of high-density lipoprotein cholesterol physiological parameter 12 weeks
Primary weight in kilograms physiological parameter 12 weeks
Primary height in meters physiological parameter 12 weeks
Primary body mass index (BMI) BMI=weight(kg)/height^2(m) 12 weeks
Primary waist circumference physiological parameter 12 weeks
Primary hip measurement physiological parameter 12 weeks
Primary Systolic blood pressure physiological parameter 12 weeks
Primary Diastolic blood pressure physiological parameter 12 weeks
Secondary Number of Participants who take drugs This indicator refers to the number of participants taking medication. 12 weeks
Secondary Incidence of diabetes complications This indicator refers to the proportion of participants experiencing complications from diabetes. 12 weeks
Secondary Rate of smoking among participants This indicator refers to the proportion of participants who smoke. 12 weeks
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