This group will have their habitual diet supplemented with 30 to 45g (1 to 1.5 oz) of walnuts daily.

This group will eat their habitual diet and refrain from eating walnuts.

Age Related Cognitive Decline

Age Related Macular Degeneration

Walnuts

habitual diet

Loma Linda University, Department of Nutrition

Hospital Clinic, University of Barcelona

Walnuts and Healthy Aging

Effect of Daily Ingestion of Walnuts for 2 Years on Age-related Cognitive Decline and Macular Degeneration in Healthy Elderly Subjects: A Randomized, Single Blind, Dual Center, Controlled Trial

The composite score will be calculated using the scores from the tests listed below. We will calculate the standardized scores of each test as the score of each participant minus the group mean and divide by its standard deviation. The composite score is the mean of the standardized scores.
The 12 tests are: Rey Auditory Verbal Learning Test (RAVLT), Rey-Osterrieth Complex Figure (ROCF), Semantic Fluency (Animals), Boston Naming Test (BNT), Visual Object and Space Perception Battery (VOSP), Block Design section from the Wechsler Adult Intelligence Scale (WAIS-III), Trail Making Test (TMT), FAS Word Fluency, Stroop Color Word Test, Symbol Digit Modalities Test (SMDT) Digit Span from the WAIS-III and Conners Continuous Performance Test (CPT-II).

This will be assessed: by stereoscopic digitized color fundus images graded by International Classification System for Age-Related Maculopathy (score range. 0 to 4; the higher the score, the worse the condition); by optical coherence tomography (OCT) measurements of macular thickness (in µm); by optical coherence tomography (OCT) measurements of retinal nervous fiber layer thickness (in µm).

Changes will be assessed by brain magnetic resonance imaging (MRI) on a randomly selected subset of participants. Only in Barcelona center. Unit of measure is mm2.

Changes will be assessed by brain magnetic resonance imaging (MRI) using GM density maps on a randomly selected subset of participants. Only in Barcelona center. Unit of measure is GM density.

Changes will be assessed by brain magnetic resonance imaging (MRI) on a randomly selected subset of participants. Only in Barcelona center. Unit of measure is mL.

Changes will be assessed by brain magnetic resonance imaging (MRI) on a randomly selected subset of participants. Only in Barcelona center. Unit of measure is ml/100 g/min.

Changes will be assessed by Functional MRI (fMRI) on a randomly selected subset of participants. Only in Barcelona center. There are no units of measure.

Changes will be assessed by high-resolution ultrasound. Only in Barcelona center.

BMI will be calculated as weight in kilograms divided by height in metres squared

Waist circumference will be measured to the nearest 0.5 cm by using an anthropometric tape midway between the lowest rib and at the iliac crest at minimal respiration

Changes will be assessed by Dual-energy X-ray absorptiometry. Only in Barcelona center.

Fasting serum total cholesterol will be measured by a standard enzymatic method

Fasting serum LDL-cholesterol will be estimated by the Friedewald formula

Fasting serum HDL-cholesterol will be measured by a precipitation technique

Fasting triglycerides will be measured by a standard enzymatic method

Joan Sabate,DrPH, MD

Principal Investigator, Chair, Department of Nutrition

Loma Linda University

University of Barcelona

Participants on this arm will receive a dietary supplement of OmegaVia soybean oil soft gels as a placebo for 8 weeks with bi-weekly follow-up visits to monitor side effects and compliance.

Participants will receive OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight (8) weeks with bi-weekly follow-up visits for monitoring of side effects and compliance and data collection.

As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.

Soybean Oil Soft Gels Control Group

As the intervention group, participants received a dietary supplement of Omega Via fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits to resupply the soft-gels, monitoring of side effects and compliance and data collection.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Each participants took three soft gels of fish oil omega-3 fatty acid per day, each containing more EPA (0.715 grams) than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.

Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group

Total

Sex: Female, Male

Region of Enrollment

Gestation age

Cluster of differentiation 4 (CD4) cell count

Mid-upper-arm circumference (MUAC)

Beck Depression Inventory Second Edition (BDI-II) Scale is a 21-item scoring tool which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe).Scores for each symptom are added up to obtain the total scores for all 21 items, which are interpreted as follows: Scores of 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression and 29-63: severe depression.

BDI-II depressive symptom scores

Marital status

Parity

Education status

Employment status

Household income per month

HIV status knowledge before pregnancy

HIV status disclosure to anyone

prevention of mother-to-child transmission program m2m support group meeting attendance

Experienced stressful life event

Dietary vitamin C

Dietary vitamin B1

Dietary vitamin B6

Dietary vitamin B12

Dietary folate

Dietary Iron

Dietary vitamin E

Dietary calcium

Dietary selenium

Dietary zinc

Dietary total omega-3

Depressive symptoms were assessed by Beck Depression Inventory Second Edition (BDI-II) Scoring scale at Baseline and end of study during the 8- week study period. The BDI-II Scale is a 21-item scoring tool which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe).Scores for each symptom are added up to obtain the total scores for all 21 items, which are interpreted as follows: Scores of 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression and 29-63: severe depression. The change in BDI-II scores were computed from post-intervention scores at week 8 and baseline BDI-II scores at week 0.

As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.

Change in BDI-II Depressive Symptom Scores

Fish Oil Omega-3 EPA-rich Experimental Group

Overall Study

Mrs. Rose Okoyo Opiyo

Participants on this arm received a dietary supplement of OmegaVia soybean oil soft gels as a placebo for 8 weeks with bi-weekly follow-up visits to monitor side effects and compliance.
Soybean oil soft gels: Each participant received OmegaVia soybean oil soft gels to take orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.

Soybean Oil Soft Gels

Participants received OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight (8) weeks with bi-weekly follow-up visits for monitoring of side effects and compliance and data collection.
Fish oil omega-3 EPA-rich soft gels: A total of 3.0g of OmegaVia fish oil omega-3 EPA-rich soft gels was taken orally per day as one soft gel in the morning, mid-day and evening after meals for 8 weeks with bi-weekly follow-up visits.

Fish Oil Omega-3 EPA-rich Soft Gels

Depressive Symptoms

Each participant will receive OmegaVia soybean oil soft gels to take orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks

Soybean oil soft gels

A total of 3.0g of OmegaVia fish oil omega-3 EPA-rich soft gels will be taken orally per day as one soft gel in the morning, mid-day and evening after meals for 8 weeks with bi-weekly follow-up visits.

Fish oil omega-3 EPA-rich soft gels

Nairobi City Council Health Facilities

Omega-3 Supplementation and Depression Clinical Trial

Role of Omega-3 Fish Oil Fatty Acids on Depression Among HIV-seropositive Pregnant Pregnant Women in Nairobi: A Randomized Double-blind Controlled Trial

juglans/atrofiya

Walnuts and Healthy Aging

Omega-3 Supplementation and Depression Clinical Trial

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