Microbiota
Conditions
Brief summary
Several human intervention studies have also been performed that demonstrated beneficial effects of high polyphenol fruits and vegetable on the intestinal microbiome. No information is available about the effect of spice consumption on the gut microbiome. This proposed pilot study will assess the ability of daily consumption of 5 grams of mixed spices to alter the gut microbiome composition compared to placebo in a free-living population.
Detailed description
This will be a randomized, double-blinded, placebo controlled design. Thirty-one subjects will be randomized to consume either 5 grams of mixed spice or matched placebo for 2 weeks in random sequence. At baseline and week 2, fasting blood, urine and stool will be collected. In addition body weight and composition will be determined and questionnaires and 3-day food record will be completed. Stool samples will be collected for sequencing of bacterial DNA to determine changes in the microbiota. The objective of the proposed pilot study is to determine whether intake of spice per day will alter the intestinal microflora leading to an increase in formation of short chain fatty acids. Subjects will be assigned an enrollment number after signing the informed consent form approved by the UCLA Medical Internal Review Board. Eligible subjects will be enrolled into the study upon completion of screening evaluations, which include a physical exam, complete medical history, and blood drawing. This study will be conducted in healthy free-living subjects (18-65 years). Subjects consume 5 gram mixed spices or placebo capsules daily for 2 weeks. Subjects will be instructed to eat a beige diet (low fiber\<10g and low polyphenols \<3 servings of polyphenol rich fruit/vegetables per day) during the entire study period. Participants will meet with the dietitian for instructions on eating a beige diet and will be instructed to follow the diet during the entirety of the study. All spices in the spice mixture capsules contains 1g or 20% cinnamon, 1.5g or 30% oregano, 1.5g or 30% ginger, 0.85g or 17% black pepper, 0.15g or or 3% cayenne pepper for a total of 5.0g spice mixture - identical to herbs and spices sold in grocery stores for human consumption. There are no known safety issues with any of the ingredients. Placebo capsules will contain maltodextrin equivalent to mixed spice blend. Body weight will be measured on an uncarpeted surface on a scale (Detecto-Medic; Detecto-Scales; Brooklyn, NY) while wearing no shoes and after an overnight fast. Height is measured without shoes with a stadiometer (Detecto-Medic; Detecto-Scales; Brooklyn, NY) and recorded to the nearest 0.1 cm. Body composition will be measured using the Tanita-BC418 body-fat analyzer (Tanita Corp., Tokyo, Japan).
Interventions
OTHERmixed spices
All spices in the spice mixture capsules contains 1g or 20% cinnamon, 1.5g or 30% oregano, 1.5g or 30% ginger, 0.85g or 17% black pepper, 0.15g or or 3% cayenne pepper for a total of 5.0g spice mixture. They are identical to herbs and spices sold in grocery stores for human consumption.
OTHERplacebo capsule containing 5 g of maltodextrin
placebo capsule containing 5 g of maltodextrin
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy human adults age 18-65 years old * Typically consume low fiber/polyphenol diet (beige diet)-
Exclusion criteria
* Eating a high fiber/polyphenol diet or taking any medication or dietary supplement which interfere with the absorption of polyphenols. * History of gastrointestinal surgery, diabetes mellitus, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP \>160mmHg, diastolic BP \> 95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination. * Pregnant or breastfeeding * Currently uses tobacco products. * Is unable or unwilling to comply with the study protocol. * Frequently using prebiotics, probiotics, yogurt, and/or any fiber supplements * Allergy or sensitivity to spices. Subjects will be excluded if there is a prior history of such sensitivity. Since these foods are commonly eaten and allergies are rare, subjects should be aware of this sensitivity prior to entering the study. To determine this, a positive history of spices ingestion without incident will be requested. In addition, any subject with a history of allergy or anaphylaxis of any kind will be excluded * Taking antibiotics or laxatives within the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo | 2-weeks | Change in microbial phylum abundance (% of total) between spice and placebo after two week intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Short-chain Fatty Acids (SCFAs) at 2 Weeks | 2 weeks | Change 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Placebo Group Healthy participants consume placebo capsule containing 5 g of maltodextrin
Placebo capsules contain 5 g maltodextrin. | 16 |
| Total | 31 |
Baseline characteristics
| Characteristic | Mixed Spices Intervention Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 34.8 years STANDARD_DEVIATION 12.2 | 35.6 years STANDARD_DEVIATION 13.7 | 35.2 years STANDARD_DEVIATION 12.7 |
| BMI | 28.3 kg/m^2 STANDARD_DEVIATION 6.8 | 26.7 kg/m^2 STANDARD_DEVIATION 4.4 | 27.5 kg/m^2 STANDARD_DEVIATION 5.7 |
| Race/Ethnicity, Customized African American | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Multi-racial | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 7 Participants | 9 Participants | 16 Participants |
| Region of Enrollment United States | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 2 / 15 | 0 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 |
Outcome results
Primary
Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo
Change in microbial phylum abundance (% of total) between spice and placebo after two week intervention
Time frame: 2-weeks
Population: Data from one participant from spice group and one from placebo group were excluded due to non-compliance with the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mixed Spices Intervention Group | 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 |
| Mixed Spices Intervention Group | 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 |
| Mixed Spices Intervention Group | 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 |
| Mixed Spices Intervention Group | 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 |
| Placebo Group | Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo | Phylum Bacteroidetes at Week 2 | 22.6 percentage of total bacteria | Standard Deviation 8.4 |
| Placebo Group | Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo | Phylum Firmicutes at Baseline | 65.9 percentage of total bacteria | Standard Deviation 9.2 |
| Placebo Group | Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo | Phylum Bacteroidetes at Baseline | 25.9 percentage of total bacteria | Standard Deviation 7.9 |
| Placebo Group | Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo | Phylum Firmicutes at Week 2 | 70.1 percentage of total bacteria | Standard Deviation 8.9 |
Comparison: Comparison was made to 2 weeks minus baseline changes in phylum Firmicutes abundance between groups.p-value: 0.033ANOVA
Comparison: Comparison was made to 2 weeks minus baseline changes in phylum Bacteroidetes abundance between groups.p-value: 0.097ANOVA
Secondary
Change From Baseline in Short-chain Fatty Acids (SCFAs) at 2 Weeks
Change 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.
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mixed Spices Intervention Group | Change From Baseline in Short-chain Fatty Acids (SCFAs) at 2 Weeks | Total SCFAs at Baseline | 595.6 micromole/g | Standard Deviation 311.6 |
| Mixed Spices Intervention Group | 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 |
| Placebo Group | Change From Baseline in Short-chain Fatty Acids (SCFAs) at 2 Weeks | Total SCFAs at Baseline | 678.0 micromole/g | Standard Deviation 328.1 |
| Placebo Group | Change From Baseline in Short-chain Fatty Acids (SCFAs) at 2 Weeks | Total SCFAs at week 2 | 733.7 micromole/g | Standard Deviation 443.8 |
Comparison: Comparison was made to 2 weeks minus baseline in mixed spices intervention groupp-value: 0.49t-test, 2 sided
Comparison: Comparison was made to 2 weeks minus baseline in placebo groupp-value: 0.53t-test, 2 sided