Digestive health in healthy adults at high risk of colorectal cancer Digestive System
Conditions
Interventions
Forty participants were randomised into either the intervention or control group, with each group having 20 participants. Randomisation was performed by an independent statistician on a 1:1 allocation
Sponsors
Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chinese aged 50 or above 2. Categorised as a high risk group for the development of CRC (score 4-7) by the Asian-Pacific Colorectal Screening tool (APCS) 3. No gastrointestinal symptoms suggestive of colorectal cancer 4. Negative fecal occult blood test or negative colonoscopy findings for CRC within 1 year 5. No history of food allergy 6. No dietary restriction 7. Not currently taking cholesterol-lowering medications 8. Not currently taking non-steroidal anti-inflammatory drugs (NSAIDs) 9. No probiotic and prebiotics use for the past 3 months 10. No history of gallstones 11. No Chinese medicine use (except traditional Chinese soup) for the past 3 months 12. No antibiotic taking for the past 3 months
Exclusion criteria
Exclusion criteria: 1. Having lower gastrointestinal symptoms in the past week 2. Currently pregnant unless sterilization was done or in menopause or lactating (self-reported by the participants) 3. Diagnosed to have diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Bacterial diversity in the intestinal microbiota of participants, measured by 16S metagenomic sequencing of the stool samples provided by participants, at baseline, 6 weeks, 12 weeks and 24 weeks after start of intervention 2. The Firmicutes/Bacteroidetes ratio of the bacterial community in the intestine of participants, measured by 16S metagenomic sequencing of the stool samples provided by participants, at baseline, 6 weeks, 12 weeks and 24 weeks after start of intervention 3. Serum level of high-sensitivity C-reactive protein of participants, measured by solid-phase enzyme-linked immunosorbent assay using the blood samples provided by participants, at baseline, 6 weeks, 12 weeks and 24 weeks after start of intervention 4. Faecal level of calprotectin of participants, measured by sandwich enzyme-linked immunosorbent assay using the stool samples provided by participants, at baseline, 6 weeks, 12 weeks and 24 weeks after start of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate, measured by the number of subjects recruited over the subject recruitment period, and the proportion of recruited participants in relation to the total number of potential subjects approached during subject recruitment. This was measured at baseline 2. Retention rate, measured by the proportion of subjects having completed the intervention in relation to the total number of recruited subjects. This was measured at 24 weeks after start of intervention 3. Compliance rate, measured by the proportion of the actual number of times of rice bran consumption in relation to the expected number of times of rice bran consumption among the subjects. This was measured at 24 weeks after start of intervention 4. Bowel patterns of participants, measured by the description of the shape and amount of stool egested by the participants and frequency of egestion each day during the intervention. This was measured throughout the 24-week intervention via a log-book provided to each participant 5. Adverse events, measured by the daily reporting on the experience of any abdominal pain and/or abdominal discomfort by the participants during the intervention. This was measured throughout the 24-week intervention via a log-book provided to each participant | — |
Countries
China, Hong Kong
Outcome results
None listed