Trial Outcomes & Findings for Effect of Spice Consumption on the Microbiome (NCT NCT03676803)
NCT ID: NCT03676803
Last Updated: 2019-11-19
Results Overview
Change in microbial phylum abundance (% of total) between spice and placebo after two week intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
2-weeks
Results posted on
2019-11-19
Participant Flow
Interested participants who responded to the approved flyers called the research site and a coordinate conducted a screening by utilizing a screening script. Initial eligibility was determined by a telephone conversation. Eligible subjects were scheduled for a screen visit.
After one week run-in period, thirty-one participants were enrolled and randomized into mixed-spices intervention group and placebo group. All have completed the two-week intervention study.
Participant milestones
| Measure |
Mixed Spices Intervention Group
Healthy participants consume a capsule containing 5 g of mixed spices at culinary dose
Mixed spice capsules contain 1 g cinnamon, 1.5 g oregano, 1.5 g ginger, 0.85g black pepper and 0.15g cayenne pepper for a total of 5.0 g. They are identical to herbs and spices sold in grocery stores for human consumption.
|
Placebo Group
Healthy participants consume placebo capsule containing 5 g of maltodextrin
Placebo capsules contain 5 g maltodextrin.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Spice Consumption on the Microbiome
Baseline characteristics by cohort
| Measure |
Mixed Spices Intervention Group
n=15 Participants
Healthy participants consume a capsule containing 5 g of mixed spices at culinary dose
Mixed spice capsules contain 1 g cinnamon, 1.5 g oregano, 1.5 g ginger, 0.85g black pepper and 0.15g cayenne pepper for a total of 5.0 g.
|
Placebo Group
n=16 Participants
Healthy participants consume placebo capsule containing 5 g of maltodextrin
Placebo capsules contain 5 g maltodextrin.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
35.6 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
35.2 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
BMI
|
28.3 kg/m^2
STANDARD_DEVIATION 6.8 • n=5 Participants
|
26.7 kg/m^2
STANDARD_DEVIATION 4.4 • n=7 Participants
|
27.5 kg/m^2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2-weeksPopulation: Data from one participant from spice group and one from placebo group were excluded due to non-compliance with the protocol.
Change in microbial phylum abundance (% of total) between spice and placebo after two week intervention
Outcome measures
| Measure |
Mixed Spices Intervention Group
n=14 Participants
Healthy participants consume a capsule containing 5 g of mixed spices daily for 2 weeks
|
Placebo Group
n=15 Participants
Healthy participants consumed placebo capsules daily for 2 weeks.
|
|---|---|---|
|
Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo
Phylum Firmicutes at Week 2
|
58.7 percentage of total bacteria
Standard Deviation 13.3
|
70.1 percentage of total bacteria
Standard Deviation 8.9
|
|
Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo
Phylum Firmicutes at Baseline
|
65.1 percentage of total bacteria
Standard Deviation 10.5
|
65.9 percentage of total bacteria
Standard Deviation 9.2
|
|
Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo
Phylum Bacteroidetes at Baseline
|
28.2 percentage of total bacteria
Standard Deviation 11.9
|
25.9 percentage of total bacteria
Standard Deviation 7.9
|
|
Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo
Phylum Bacteroidetes at Week 2
|
33.6 percentage of total bacteria
Standard Deviation 13.5
|
22.6 percentage of total bacteria
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 2 weeksChange from baseline in total SCFAs including acetate, propionate, butyrate and valerate in response to mixed-spice intervention for 2 weeks. SCFAs were measured in dry fecal sample determined as micromole per gram of dry weight.
Outcome measures
| Measure |
Mixed Spices Intervention Group
n=14 Participants
Healthy participants consume a capsule containing 5 g of mixed spices daily for 2 weeks
|
Placebo Group
n=15 Participants
Healthy participants consumed placebo capsules daily for 2 weeks.
|
|---|---|---|
|
Change From Baseline in Short-chain Fatty Acids (SCFAs) at 2 Weeks
Total SCFAs at Baseline
|
595.6 micromole/g
Standard Deviation 311.6
|
678.0 micromole/g
Standard Deviation 328.1
|
|
Change From Baseline in Short-chain Fatty Acids (SCFAs) at 2 Weeks
Total SCFAs at week 2
|
681.6 micromole/g
Standard Deviation 333.2
|
733.7 micromole/g
Standard Deviation 443.8
|
Adverse Events
Mixed Spices Intervention Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mixed Spices Intervention Group
n=15 participants at risk
Healthy participants consume a capsule containing 5 g of mixed spices at culinary dose
Mixed spice capsules contain 1 g cinnamon, 1.5 g oregano, 1.5 g ginger, 0.85g black pepper and 0.15g cayenne pepper for a total of 5.0 g.
|
Placebo Group
n=16 participants at risk
Healthy participants consume placebo capsule containing 5 g of maltodextrin
Placebo capsules contain 5 g maltodextrin.
|
|---|---|---|
|
Gastrointestinal disorders
stomach discomfort
|
13.3%
2/15 • Number of events 2 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place