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

Jingjing Jiao

Status: Completed

Conditions: Bone Mineral Density; Cognitive Decline; Sleep

Treatments: Dietary Supplement: High-dose fish oil capsules; Dietary Supplement: Low-dose fish oil capsules; Dietary Supplement: Refined olive oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06614374

RCT_N3_SUPPLE

Details and patient eligibility

About

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.

Enrollment: 415 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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415 participants in 3 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Subjects will receive equivalent amounts of refined olive oil daily.

Treatment:

Dietary Supplement: Refined olive oil

Low-dose fish oil group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Low-dose fish oil capsules

High-dose fish oil group

Experimental group

Description:

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

Treatment:

Dietary Supplement: High-dose fish oil capsules