Trial Outcomes & Findings for Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer (NCT NCT04211766)
NCT ID: NCT04211766
Last Updated: 2024-09-27
Results Overview
This grant is an R21 with the intent to provide preliminary data to propose a trial with a larger sample size and adequate statistical power.
COMPLETED
NA
38 participants
Baseline to completion of the 2 study time periods
2024-09-27
Participant Flow
Recruitment occurred December 2020 thru March 2022 via ads, fliers and social media in the Seattle area. We received 243 screening questionnaires; 88 were incomplete. Of 155 completed, 95 were ineligible (61.3%). We contacted the 60 eligible; 43 attended orientation; 38 signed consent. Three were not randomized (2 ineligible based on abnormal clinical lab tests at baseline and 1 withdrew because of stool collection). Overall, we met planned recruitment goals.
Before randomization to determine the crossover order of supplements (active-washout-comparison, or comparison-washout-active), consented participants had a blood draw. Samples were sent to CLIA-certified Quest Labs for kidney/liver function tests as part of eligibility criteria. Two of the 38 were ineligible based on the lab test criteria. Additionally, 1 person decided they did not want to enter the trial and was not randomized.
Participant milestones
| Measure |
Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator
Period 1: Fiber and Fish oil supplements (30 days) Washout: at least 60 days Period 2: Comparator supplements (30 days)
|
Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil
Period 1: Comparator supplements (30 days) Washout: at least 60 days Period 2: Fiber and Fish oil supplements (30 days)
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
16
|
|
Overall Study
Completed Only Period 1
|
1
|
1
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator
Period 1: Fiber and Fish oil supplements (30 days) Washout: at least 60 days Period 2: Comparator supplements (30 days)
|
Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil
Period 1: Comparator supplements (30 days) Washout: at least 60 days Period 2: Fiber and Fish oil supplements (30 days)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
Baseline Characteristics
Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator
n=15 Participants
Participants received a fiber supplement and fish oil supplement PO daily for 30 days. After a washout period, of at least 60 days, they received the comparator supplements (also for 30 days)
|
Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil
n=16 Participants
Participants received the comparator supplements PO daily for 30 days. After a washout period, of at least 60 days, they received the fiber supplement and fish oil supplement (also for 30 days)
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to completion of the 2 study time periodsPopulation: All participants who consented and started the intervention.
This grant is an R21 with the intent to provide preliminary data to propose a trial with a larger sample size and adequate statistical power.
Outcome measures
| Measure |
Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator
n=19 Participants
Period 1: participants receive fiber supplement and fish oil supplement PO daily on days 1-30.
Washout: at least 60 days. Period 2: participants receive the comparators supplements also PO daily on days 90-120.
|
Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil
n=16 Participants
For Period 1: participants receive comparator supplements PO daily on days 1-30.
Participants enter a washout period for at least 60 days. For Period 2: participants receive fiber supplement and fish oil supplement also PO daily on days 90-120.
|
|---|---|---|
|
Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators)
Participants who dropped out during Period 1
|
4 Participants
|
0 Participants
|
|
Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators)
Participants with complete measures (who completed Period 1 and Period 2)
|
14 Participants
|
15 Participants
|
|
Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators)
Participants with partial measures (who only completed Period 1)
|
1 Participants
|
1 Participants
|
|
Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators)
Participants who dropped out during Period 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: End of Fiber Plus Fish Oil Supplementation vs end of ComparatorPopulation: All participants who completed both the Fiber Plus Fish Oil Supplement and the Comparator intervention periods in this crossover study and had stools at the end of each intervention period were included in the analysis. RNA-Seq data from stool for 29 participants were analyzed for differential gene expression comparing the end of each intervention period.
Poly A+ RNA was isolated from exfoliated cells in stool, and libraries generated from stool RNA and sequenced on an Illumina HiSeq 2500 platform. Intestinal exfoliome gene sequencing data from the end of each intervention period were analyzed using differential expression (DE) analysis. Count data were aligned, and sample libraries were filtered and normalized; 25,118 detected features were filtered to keep any feature with \>20 cpm in 73% of samples in at least one of the groups; this resulted in 1000 genes. DE analysis between Fiber Plus Fish Oil Supplement vs the Comparator at the end time point was performed using edgeR with a paired design (Robinson et al, Bioinformatics 2010;26:139). Data are presented as number of DE genes significant at p \< 0.01 (without multiple test correction). Upregulated genes indicate higher gene expression with Fiber Plus Fish Oil vs the Comparator and downregulated genes indicate lower gene expression with Fiber Plus Fish Oil vs the Comparator.
Outcome measures
| Measure |
Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator
n=1000 genes
Period 1: participants receive fiber supplement and fish oil supplement PO daily on days 1-30.
Washout: at least 60 days. Period 2: participants receive the comparators supplements also PO daily on days 90-120.
|
Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil
For Period 1: participants receive comparator supplements PO daily on days 1-30.
Participants enter a washout period for at least 60 days. For Period 2: participants receive fiber supplement and fish oil supplement also PO daily on days 90-120.
|
|---|---|---|
|
Number of Differentially Expressed Exfoliome Genes at p<0.01
Upregulated
|
10 number of genes at p<0.01
|
—
|
|
Number of Differentially Expressed Exfoliome Genes at p<0.01
Downregulated
|
2 number of genes at p<0.01
|
—
|
|
Number of Differentially Expressed Exfoliome Genes at p<0.01
Unchanged
|
988 number of genes at p<0.01
|
—
|
SECONDARY outcome
Timeframe: Average at the end of each intervention periodSerum Phospholipids - Eicosapentaenoic acid (EPA), concentration
Outcome measures
| Measure |
Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator
n=31 Participants
Period 1: participants receive fiber supplement and fish oil supplement PO daily on days 1-30.
Washout: at least 60 days. Period 2: participants receive the comparators supplements also PO daily on days 90-120.
|
Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil
n=31 Participants
For Period 1: participants receive comparator supplements PO daily on days 1-30.
Participants enter a washout period for at least 60 days. For Period 2: participants receive fiber supplement and fish oil supplement also PO daily on days 90-120.
|
|---|---|---|
|
Compliance
|
43.9 mg/L
Standard Deviation 29.7
|
3.6 mg/L
Standard Deviation 3.0
|
Adverse Events
Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator
Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place