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

Not Applicable

Completed

• Conditions: Cognitive Decline; Sleep; Bone Mineral Density
• Interventions: Dietary Supplement: Refined olive oil; Dietary Supplement: Low-dose fish oil capsules; Dietary Supplement: High-dose fish oil capsules

• Registration Number: NCT06614374
• Lead Sponsor: Jingjing Jiao

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-10
• Primary Completion: 2022-01-02
• Study Completion: 2022-02-28
• Status Verified: 2024-09
• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-24
• Last Update Submitted: 2024-09-24
• Study First Posted: 2024-09-26
• Last Update Posted: 2024-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 415

Inclusion Criteria

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

Exclusion Criteria

1. type 1 diabetes; 2) coronary heart disease, stroke, cancer, hepatic or kidney disease; 3) pregnancy or lactation; 4) allergy to fish; 5) have participated in other clinical trials in the last three months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Refined olive oil	Subjects will receive equivalent amounts of refined olive oil daily.
Low-dose fish oil group	Low-dose fish oil capsules	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
High-dose fish oil group	High-dose fish oil capsules	Subjects will receive four fish oil capsules containing 3 g of marine n-3 PUFAs (72% EPA and 28% DHA) per day

Primary Outcome Measures

Name	Time	Method
Bone mineral density	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.
Sleep quality	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.
Cognitive function	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.

Trial Locations

Locations (1)

Lanxi Red Cross Hospital; 🇨🇳 Jinhua, Zhejiang, China