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The primary aim of the pilot study is to provide data that can be used to better determine sample size for the design of a larger clinical trial. The pilot will evaluate the effectiveness of Lipoic Acid (LA) plus Omega-3 fatty acids (Omega-3) on preventing Alzheimer's Disease (AD). The investigators will also collect data to evaluate recruitment rate, safety, and compliance over the 12 month study period.
The primary aim is to collect data so that we can determine effect size between lipoic acid plus omega-3 fatty acids and placebo on the primary outcome measure Trails B (executive function). This is designed as a pilot randomized, double-blind, placebo-controlled study with a 12 month intervention period. Thirty participants diagnosed with hypertension that is treated (systolic blood pressure 90-160 mm Hg, diastolic blood pressure 60-90 mm Hg) that have low omega-3 fatty acid levels, and normal cognitive function will be randomized to receive study drug or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo LA capsules per day. Capsules will be taken with food or a meal. |
|
| Lipoic acid plus omega-3 fatty acids | Experimental | Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg docosahexaenoic acid (DHA) and 975 mg eicosapentaenoic acid (EPA) plus 2 LA capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipoic Acid plus Omega-3 Fatty Acids | Drug | alpha lipoic acid (racemic) and fish oil concentrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trails Making Test Part B (Executive Function) | The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient as he or she connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. | Baseline, 6 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| White Matter Hyperintensity Volume (Brain MRI) | Baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynne Shinto, ND, MPH | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lynne Shinto, ND, MPH | Portland | Oregon | 97239 | United States | ||
| Oregon Health & Science University |
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Med exclusions included Omega-3 fatty acid supplement intake < 4 months prior to enrollment; Lipoic acid supplementation < 1 month prior to enrollment; stable dosage for 4 months prior to enrollment of antihypertensive medication and (if prescribed) lipid lowering medication. Other exclusions included labs and test scores out of range.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate |
| FG001 | Lipoic Acid Plus Omega-3 Fatty Acids | Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate |
| BG001 | Lipoic Acid Plus Omega-3 Fatty Acids | Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Trails Making Test Part B (Executive Function) | The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient as he or she connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. | Not all tests were completed by all randomized subjects due to missed visits and/or discontinuations. | Posted | Mean | Standard Deviation | time to completion (seconds) | Baseline, 6 months, and 12 months |
|
From baseline to 12 months (end of treatment)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | placebo capsules |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Benign peripheral position vertigo requiring hospitalization | Nervous system disorders | Vertigo positional | Systematic Assessment | Hospitalized overnight with diagnosis of benign peripheral positional vertigo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
No Omega-3 only or lipoic acid only arm; not excluding over-the-counter medications and supplements
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynne Shinto, ND, MPH | Oregon Health & Science University | 503-494-5035 | shintol@ohsu.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| D015525 | Fatty Acids, Omega-3 |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Placebo | Drug | placebo capsules |
|
| Portland |
| Oregon |
| 97239 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Apo E4 Carrier | Apo E data for 2 participants missing | Count of Participants | Participants |
|
| Systolic BP | Mean | Standard Deviation | mmHg |
|
| Diastolic BP | Mean | Standard Deviation | mmHg |
|
| Exercise | Demographic information form missing for 3 participants | Count of Participants | Participants |
|
| Smoking | Demographic information missing for 2 participants | Count of Participants | Participants |
|
| Arachidonic Acid (AA) | Mean | Standard Deviation | % composition of blood |
|
| Eicosapentaenoic Acid (EPA) | Mean | Standard Deviation | % composition of blood |
|
| Docosahexaenoic Acid (DHA) | Mean | Standard Deviation | % composition of blood |
|
| OG000 | Placebo | Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo lipoic acid capsules per day. Capsules will be taken with food or a meal. Placebo: placebo capsules |
| OG001 | Lipoic Acid Plus Omega-3 Fatty Acids | Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg DHA and 975 mg EPA plus 2 lipoic acid capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal. Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate |
|
|
| Secondary | White Matter Hyperintensity Volume (Brain MRI) | At baseline, 4 participants either could not complete the MRI or the MRI could not be analyzed due to quality; at 12 months, 13 participants either discontinued, could not complete the MRI, or did not complete the baseline and therefore were not scanned. | Posted | Mean | Standard Deviation | cubic centimeters | Baseline and 12 months |
|
|
|
| 3 |
| 21 |
| 16 |
| 21 |
| EG001 | Lipoic Acid Plus Omega-3 Fatty Acids | Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate | 1 | 21 | 17 | 21 |
|
| Severe angina with worsening symptoms | Cardiac disorders | Angina unstable | Systematic Assessment | Severe angina with worsening symptoms, hospitalized and admitted for coronary bypass surgery |
|
| Suicide attempt | Psychiatric disorders | Suicide attempt | Systematic Assessment | Hospitalized after suicide attempt |
|
| Death from unknown cardiac event | Cardiac disorders | Cardiac death | Systematic Assessment | Death from cardiac event |
|
| Dizziness/Vertigo | Vascular disorders | Systematic Assessment |
|
| Arm pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Suicidal ideations & behaviors | Psychiatric disorders | Systematic Assessment |
|
| Accident-related injuries | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Supplement-related difficulties | Gastrointestinal disorders | Systematic Assessment | Expected side-effects from supplement (i.e., trouble swallowing, fish burps) |
|
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | Systematic Assessment | Surgeries for pre-existing conditions |
|
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| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D005231 | Fatty Acids, Unsaturated |
| D009821 | Oils |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Completed college |
|
| Masters/Graduate School |
|
| Exercises 2+ times/week |
|
| Smoker |
|
| 12 Months |
|
|