Cognitive Decline, Sleep, Bone Mineral Density
Conditions
Keywords
Fish oil, Omega-3 fatty acids, cognitive function, sleep quality, bone density
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.
Interventions
DIETARY_SUPPLEMENTLow-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_SUPPLEMENTHigh-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_SUPPLEMENTRefined olive oil
Participants in the control group will receive 4 g refined olive oil daily
Sponsors
Jingjing Jiao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed