MicrobiotaNCT03676803
Effect of Spice Consumption on the Microbiome
A study testing mixed spices in people with Microbiota, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota
- What is being tested?
- mixed spices
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2017to 30 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy human adults age 18-65 years old
- Typically consume low fiber/polyphenol diet (beige diet)-
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition, 900 Veteran Ave.
Los Angeles, California, 90095
About this study
Official title: Effect of Spice Consumption on the Microbiome in Healthy Subjects: A Pilot Study
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.
Read the 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).
- Conditions
- Microbiota
- Being tested
- mixed spices, placebo capsule containing 5 g of maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mixed spicesOther
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.
placebo capsule containing 5 g of maltodextrinOther
placebo capsule containing 5 g of maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Mixed spices intervention group | Experimental | healthy participants consume a capsule containing 5 g of mixed spices at culinary dose Receives: Other: mixed spices |
| placebo group | Placebo comparator | healthy participants consume placebo capsule containing 5 g of maltodextrin Receives: Other: placebo capsule containing 5 g of maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2-weeks
Secondary outcomes (1)
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start3 Aug 2017
- Primary completion17 Nov 2017
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, MD, PhD, Principal investigator, Center for Human Nutrition, UCLA David Geffen School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676803
- Sponsor's protocol ID
- IRB#17-000617
- Status last verified
- Nov 2019
- First submitted
- 17 Sep 2018
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spice Consumption on the Microbiome in Healthy Subjects: A Pilot Study
- ClinicalTrials.gov ID
- NCT03676803
- Acronym / sponsor ID
- IRB#17-000617
- Conditions
- Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Posted 19 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mixed spices intervention group | Experimental | Other: mixed spiceshealthy participants consume a capsule containing 5 g of mixed spices at culinary dose |
| placebo group | Placebo comparator | Other: placebo capsule containing 5 g of maltodextrinhealthy participants consume placebo capsule containing 5 g of maltodextrin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy human adults age 18-65 years old
- Typically consume low fiber/polyphenol diet (beige diet)-
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mixed spicesAll 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. | Other | Mixed spices intervention group |
| placebo capsule containing 5 g of maltodextrinplacebo capsule containing 5 g of maltodextrin | Other | placebo group |
Primary outcome
Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo
Time frame: 2-weeks
Change in microbial phylum abundance (% of total) between spice and placebo after two week intervention
1 secondary outcome
Change From Baseline in Short-chain Fatty Acids (SCFAs) at 2 Weeks
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoping Li, MD, PhD principal investigator
Center for Human Nutrition, UCLA David Geffen School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mixed spices in people with Microbiota, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo (time frame: 2-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.