NCT06614374

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 415 (actual)
• Sponsor: Jingjing Jiao · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cognitive Decline
• Sleep
• Bone Mineral Density

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
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.
DIETARY_SUPPLEMENT	Refined olive oil	Participants in the control group will receive 4 g refined olive oil daily

Timeline

• Start date: 2020-10-10
• Primary completion: 2022-01-02
• Completion: 2022-02-28
• First posted: 2024-09-26
• Last updated: 2025-08-13

Locations

1 site across 1 country: China