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

NCT06614374 | Completed

• 1 other identifier: RCT_N3_SUPPLE
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Decline; Sleep; Bone Mineral Density

Keywords

Fish oil; Omega-3 fatty acids; cognitive function; sleep quality; bone density

Outcome Measures

Primary Outcomes (3)

• Bone mineral density

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

  Baseline and 1 year

• Sleep quality

  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.

  Baseline and 1 year

• Cognitive function

  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.

  Baseline and 1 year

Study Arms (3)

Control group

PLACEBO COMPARATOR

Subjects will receive equivalent amounts of refined olive oil daily.

Dietary Supplement: Refined olive oil

Low-dose fish oil group

EXPERIMENTAL

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

Dietary Supplement: Low-dose fish oil capsules

High-dose fish oil group

EXPERIMENTAL

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

Dietary Supplement: High-dose fish oil capsules

Interventions

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.

Low-dose fish oil group

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.

High-dose fish oil group

Refined olive oil DIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jingjing Jiao: lead

Study Sites (1)

Lanxi Red Cross Hospital

Jinhua, Zhejiang, 321102, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Sleep Initiation and Maintenance Disorders

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: October 10, 2020
• Primary Completion: January 2, 2022
• Study Completion: February 28, 2022
• Last Updated: August 13, 2025

Record last verified: 2024-09

Locations

CN (1)