Trial Outcomes & Findings for Krill Oil for Pain in Elders (NCT NCT06580912)
NCT ID: NCT06580912
Last Updated: 2026-05-13
Results Overview
Adherence defined as taking at least 70% of assigned capsules during the 12-week intervention, based on participant diary records.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
From baseline through final assessment, up to 12 weeks.
Results posted on
2026-05-13
Participant Flow
Recruitment occurred from January to September 2025.
No washout or run-in period was used. After screening and written informed consent, eligible participants completed baseline assessments within 30 days before randomization; if more than 30 days elapsed, eligibility was reassessed.
Participant milestones
| Measure |
Krill Oil
4 grams of krill oil per day
|
Mixed Vegetable Oil
4 grams of mixed vegetable oil per day
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Krill Oil
4 grams of krill oil per day
|
Mixed Vegetable Oil
4 grams of mixed vegetable oil per day
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Krill Oil for Pain in Elders
Baseline characteristics by cohort
| Measure |
Krill Oil
n=20 Participants
4 grams of krill oil per day
|
Mixed Vegetable Oil
n=20 Participants
4 grams of mixed vegetable oil per day
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.4 Years
STANDARD_DEVIATION 5.5 • n=1512 Participants
|
70.7 Years
STANDARD_DEVIATION 5.9 • n=504 Participants
|
70.1 Years
STANDARD_DEVIATION 5.7 • n=2016 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=1512 Participants
|
10 Participants
n=504 Participants
|
20 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=1512 Participants
|
10 Participants
n=504 Participants
|
20 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=1512 Participants
|
16 Participants
n=504 Participants
|
33 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
6 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=1512 Participants
|
18 Participants
n=504 Participants
|
34 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Body mass index
|
29.9 Kg/m^2
STANDARD_DEVIATION 7.5 • n=1512 Participants
|
31.8 Kg/m^2
STANDARD_DEVIATION 5.9 • n=504 Participants
|
30.8 Kg/m^2
STANDARD_DEVIATION 6.7 • n=2016 Participants
|
PRIMARY outcome
Timeframe: From baseline through final assessment, up to 12 weeks.Population: Analysis includes participants with evaluable self-reported diary adherence data during the 12-week intervention. Of 38 completers, 1 participant had missing diary records.
Adherence defined as taking at least 70% of assigned capsules during the 12-week intervention, based on participant diary records.
Outcome measures
| Measure |
Krill Oil
n=18 Participants
4 grams of krill oil per day
|
Mixed Vegetable Oil
n=19 Participants
4 grams of mixed vegetable oil per day
|
|---|---|---|
|
Participants With 70% or Greater Adherence Based on Self-reported Daily Diary
|
18 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: From baseline through final assessment, up to 12 weeks.Population: Analysis includes participants with evaluable capsule count adherence data during the 12-week intervention. Participants were classified as adherent if capsule-count adherence was ≥70%.
Adherence defined as taking at least 70% of assigned capsules during the 12-week intervention, based on capsule count records.
Outcome measures
| Measure |
Krill Oil
n=18 Participants
4 grams of krill oil per day
|
Mixed Vegetable Oil
n=18 Participants
4 grams of mixed vegetable oil per day
|
|---|---|---|
|
Participants With 70% or Greater Adherence Based on Capsule Counts
|
15 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 6 weeks and 12 weeksPopulation: Analysis includes participants with available MAQ overall acceptability data at each time point.
The Medicine Acceptability Questionnaire (MAQ) overall acceptability item was rated on a 0 to 10 scale. Scores range from 0 to 10, with higher scores indicating greater acceptability.
Outcome measures
| Measure |
Krill Oil
n=18 Participants
4 grams of krill oil per day
|
Mixed Vegetable Oil
n=20 Participants
4 grams of mixed vegetable oil per day
|
|---|---|---|
|
Overall Acceptability Score on the Medicine Acceptability Questionnaire
Week 6
|
7.4 Scores on a scale
Standard Deviation 2.8
|
7.7 Scores on a scale
Standard Deviation 2.4
|
|
Overall Acceptability Score on the Medicine Acceptability Questionnaire
Week 12
|
8.1 Scores on a scale
Standard Deviation 2.0
|
7.4 Scores on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, and 12 weeksPopulation: Observed-case analysis including participants with available baseline and Week 12 omega-3 index data. Two randomized participants in the krill oil group withdrew before the final assessment and were not included in the Week 12 change analysis.
Omega-3 Index was calculated as eicosapentaenoic acid plus docosahexaenoic acid, or EPA+DHA, expressed as a percentage of total fatty acids in erythrocytes.
Outcome measures
| Measure |
Krill Oil
n=20 Participants
4 grams of krill oil per day
|
Mixed Vegetable Oil
n=20 Participants
4 grams of mixed vegetable oil per day
|
|---|---|---|
|
Omega-3 Index
Baseline
|
4.3 Percent EPA and DHA in erythrocytes (%)
Standard Deviation 1.1
|
4.5 Percent EPA and DHA in erythrocytes (%)
Standard Deviation 0.7
|
|
Omega-3 Index
Week 6
|
7.4 Percent EPA and DHA in erythrocytes (%)
Standard Deviation 1.6
|
4.5 Percent EPA and DHA in erythrocytes (%)
Standard Deviation 0.7
|
|
Omega-3 Index
Week 12
|
7.5 Percent EPA and DHA in erythrocytes (%)
Standard Deviation 1.8
|
4.6 Percent EPA and DHA in erythrocytes (%)
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, and 12 weeksPopulation: Observed-case analysis including participants with available hs-CRP data at each visit.
High-sensitivity C-reactive protein (hs-CRP) will be measured at every visit as an inflammatory biomarker and for safety monitoring.
Outcome measures
| Measure |
Krill Oil
n=20 Participants
4 grams of krill oil per day
|
Mixed Vegetable Oil
n=20 Participants
4 grams of mixed vegetable oil per day
|
|---|---|---|
|
High-sensitivity C-reactive Protein
Baseline
|
3.2 mg/L
Standard Deviation 4.0
|
3.6 mg/L
Standard Deviation 3.8
|
|
High-sensitivity C-reactive Protein
Week 6
|
3.2 mg/L
Standard Deviation 3.8
|
4.8 mg/L
Standard Deviation 5.5
|
|
High-sensitivity C-reactive Protein
Week 12
|
2.9 mg/L
Standard Deviation 3.7
|
5.4 mg/L
Standard Deviation 6.7
|
Adverse Events
Krill Oil
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Mixed Vegetable Oil
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Krill Oil
n=20 participants at risk
4 grams of krill oil per day
Krill oil: 4 grams of krill oil per day
|
Mixed Vegetable Oil
n=20 participants at risk
4 grams of mixed vegetable oil per day
Mixed vegetable oil: 4 grams of mixed vegetable oil per day
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20 • Number of events 2 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
50.0%
10/20 • Number of events 12 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Nervous system disorders
Headache
|
30.0%
6/20 • Number of events 8 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
10.0%
2/20 • Number of events 2 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
25.0%
5/20 • Number of events 5 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.0%
3/20 • Number of events 3 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
15.0%
3/20 • Number of events 3 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
20.0%
4/20 • Number of events 4 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
15.0%
3/20 • Number of events 3 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
10.0%
2/20 • Number of events 2 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
15.0%
3/20 • Number of events 4 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
10.0%
2/20 • Number of events 2 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Gastrointestinal disorders
Belching
|
10.0%
2/20 • Number of events 2 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
10.0%
2/20 • Number of events 2 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Number of events 2 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
10.0%
2/20 • Number of events 2 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
10.0%
2/20 • Number of events 2 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
10.0%
2/20 • Number of events 2 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
10.0%
2/20 • Number of events 2 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Injury, poisoning and procedural complications
Bruising
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Ear and labyrinth disorders
Ear pain
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
General disorders
Fatigue
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Vascular disorders
Hematoma
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Nervous system disorders
Lethargy
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/20 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
5.0%
1/20 • Number of events 1 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
|
Metabolism and nutrition disorders
Increased appetite
|
10.0%
2/20 • Number of events 2 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
15.0%
3/20 • Number of events 3 • From baseline through study completion, up to 12 weeks.
Adverse events were collected systematically from baseline through the 12-week final assessment by participant report and study staff review. The number at risk includes all randomized participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place