Fish Oil for Cognitive Function, Sleep Quality, and Bone Density

NCT ID: NCT06614374

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-10

Study Completion Date

2022-02-28

Brief Summary

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The Precision Nutritional Management for Diabetes trial (PNMD; NCT03708887) is a randomized clinical trial in 415 diabetic patients investigating whether taking daily dietary supplements of omega-3 fatty acids (1.5 or 3 grams) improves glucose and lipid homeostasis in Chinese diabetic patients. This ancillary study is being conducted among PNMD participants and will examine whether fish oil supplements affect A) cognitive function, B) sleep quality, and C) bone mineral density. Cognitive function, sleep quality, and bone mineral density will be evaluated at baseline and post-intervention. The Mini-Mental State Exams (MMSE) will be conducted to evaluate the cognitive function of participants. The Pittsburgh Sleep Quality Index (PSQI) will be calculated through questionnaires to evaluate sleep quality. The Dual-emission X-ray Absorptiometry (DXA) will be assessed to measure the bone density.

Detailed Description

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Conditions

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Cognitive Decline Sleep Bone Mineral Density

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control group

Subjects will receive equivalent amounts of refined olive oil daily.

Group Type PLACEBO_COMPARATOR

Refined olive oil

Intervention Type DIETARY_SUPPLEMENT

Participants in the control group will receive 4 g refined olive oil daily

Low-dose fish oil group

Subjects will receive four fish oil and refined olive oil mixed capsules containing 1.5 g of marine n-3 PUFAs (72% EPA and 28% DHA) per day

Group Type EXPERIMENTAL

Low-dose fish oil capsules

Intervention Type DIETARY_SUPPLEMENT

Patients in the low-dose group will receive four fish-oil and refined olive oil mixed capsules containing 1.5 g of marine n-3 PUFAs per day.

High-dose fish oil group

Subjects will receive four fish oil capsules containing 3 g of marine n-3 PUFAs (72% EPA and 28% DHA) per day

Group Type EXPERIMENTAL

High-dose fish oil capsules

Intervention Type DIETARY_SUPPLEMENT

Patients in the high-dose group will receive four fish oil capsules containing 3 g of marine n-3 PUFAs (72% EPA and 28% DHA) per day.

Interventions

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Low-dose fish oil capsules

Patients in the low-dose group will receive four fish-oil and refined olive oil mixed capsules containing 1.5 g of marine n-3 PUFAs per day.

Intervention Type DIETARY_SUPPLEMENT

High-dose fish oil capsules

Patients in the high-dose group will receive four fish oil capsules containing 3 g of marine n-3 PUFAs (72% EPA and 28% DHA) per day.

Intervention Type DIETARY_SUPPLEMENT

Refined olive oil

Participants in the control group will receive 4 g refined olive oil daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Diagnosed type 2 diabetes according to WHO diagnostic criteria or those on the use of diabetic medications;
* Between 40 and 75 years old (postmenopausal women);
* Have never used n-3 PUFA supplements before or have stopped using them for more than six months.

Exclusion Criteria

* Type 1 diabetes;
* Coronary heart disease, stroke, cancer, hepatic or kidney disease;
* Pregnancy or lactation;
* Allergy to fish;
* Have participated in other clinical trials in the last three months.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jingjing Jiao

OTHER

Sponsor Role lead

Responsible Party

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Jingjing Jiao

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Lanxi Red Cross Hospital

Jinhua, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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RCT_N3_SUPPLE

Identifier Type: -

Identifier Source: org_study_id

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