N/A
Completed N=31
Effect of Spice Consumption on the Microbiome
Microbiota
Source: ClinicalTrials.gov NCT03676803 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo — 65.1; 65.9; 58.7; 70.1 percentage of total bacteria — p=0.033
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo |
65.1; 65.9; 58.7; 70.1; 28.2; 25.9 | 0.033 sig |
| SECONDARY Change From Baseline in Short-chain Fatty Acids (SCFAs) at 2 Weeks |
595.6; 678.0; 681.6; 733.7 | 0.49 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03676803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.