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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mixed spices intervention group | Experimental | healthy participants consume a capsule containing 5 g of mixed spices at culinary dose |
|
| placebo group | Placebo Comparator | healthy participants consume placebo capsule containing 5 g of maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mixed spices | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoping Li, MD, PhD | Center for Human Nutrition, UCLA David Geffen School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Center for Human Nutrition, 900 Veteran Ave. | Los Angeles | California | 90095 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo Group | Healthy participants consume placebo capsule containing 5 g of maltodextrin Placebo capsules contain 5 g maltodextrin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Data from one participant from spice group and one from placebo group were excluded due to non-compliance with the protocol. | Posted | Mean | Standard Deviation | percentage of total bacteria | 2-weeks |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| stomach discomfort | Gastrointestinal disorders | SNOMED CT | Systematic Assessment | Bloating, nausea |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhaoping Li, MD, PhD | UCLA Center for Human Nutrition | 310-206-1987 | zli@medent.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 11, 2017 | Nov 1, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 11, 2017 | Nov 1, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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|
| placebo capsule containing 5 g of maltodextrin | Other | placebo capsule containing 5 g of maltodextrin |
|
Healthy participants consume placebo capsule containing 5 g of maltodextrin Placebo capsules contain 5 g maltodextrin. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | micromole/g | 2 weeks |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 2 |
| 15 |
| EG001 | Placebo Group | Healthy participants consume placebo capsule containing 5 g of maltodextrin Placebo capsules contain 5 g maltodextrin. | 0 | 16 | 0 | 16 | 0 | 16 |
|
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| 0.53 |
| Mean Difference (Final Values) |
| 55.7 |
| 2-Sided |
| Other |