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

Effects of n-3 Fatty Acids on Cognitive Function, Sleep Quality, and Bone Mineral Density in Diabetic Patients: an Ancillary Study of the Precision Nutritional Management for Diabetes (PNMD) Trial

NCT06614374•Jingjing Jiao

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

40 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Lanxi Red Cross Hospital

Jinhua, Zhejiang, China

Key Dates

Start Date

October 10, 2020

Primary Completion Date

January 2, 2022

Completion Date

February 28, 2022

Last Updated

August 13, 2025

Enrollment

415

ACTUAL participants

Conditions

Cognitive DeclineSleepBone Mineral Density

Interventions

Low-dose fish oil capsules

DIETARY_SUPPLEMENT

High-dose fish oil capsules

DIETARY_SUPPLEMENT

Refined olive oil

DIETARY_SUPPLEMENT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

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