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Completed

NCT Number: NCT06614374

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

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.

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Key information

Conditions

Cognitive Decline Bone Mineral Density Cognition Disorders Cognitive Dysfunction Dyssomnias Mental Disorders Nervous System Diseases Neurocognitive Disorders Sleep Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lanxi Red Cross Hospital

Jinhua, Zhejiang, 321102, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-dose fish oil capsules

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 capsules

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.

Refined Olive Oil

Dietary Supplement

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

Primary outcomes

  1. Bone mineral density

    Time frame: Baseline and 1 year

    The Dual-emission X-ray Absorptiometry (DXA) will be assessed to measure the bone mineral density at baseline and post-intervention.

  2. Sleep quality

    Time frame: Baseline and 1 year

    The Pittsburgh Sleep Quality Index (PSQI) will be calculated through questionnaires to evaluate sleep quality. The Changes in sleep quality will be quantified by the difference in PSQI scores between the baseline and the conclusion of the intervention period.

  3. Cognitive function

    Time frame: Baseline and 1 year

    The Mini-Mental State Exams (MMSE) will be conducted to evaluate the cognitive function of participants at both the start and end of the study. Changes in cognitive function will be quantified by the difference in MMSE scores between the baseline and the conclusion of the intervention period.

Sponsors and collaborators

Lead sponsor

Jingjing Jiao

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 26, 2024
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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