Effect of Spice Consumption on the Microbiome
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|ClinicalTrials.gov Identifier: NCT03676803|
Recruitment Status : Completed
First Posted : September 19, 2018
Results First Posted : November 19, 2019
Last Update Posted : November 19, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Microbiota||Other: mixed spices Other: placebo capsule containing 5 g of maltodextrin||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Spice Consumption on the Microbiome in Healthy Subjects: A Pilot Study|
|Actual Study Start Date :||August 3, 2017|
|Actual Primary Completion Date :||November 17, 2017|
|Actual Study Completion Date :||May 30, 2018|
Experimental: Mixed spices intervention group
healthy participants consume a capsule containing 5 g of mixed spices at culinary dose
Other: mixed 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.
Placebo Comparator: placebo group
healthy participants consume placebo capsule containing 5 g of maltodextrin
Other: placebo capsule containing 5 g of maltodextrin
placebo capsule containing 5 g of maltodextrin
- 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
- Change From Baseline in Short-chain Fatty Acids (SCFAs) at 2 Weeks [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676803
|United States, California|
|UCLA Center for Human Nutrition, 900 Veteran Ave.|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Zhaoping Li, MD, PhD||Center for Human Nutrition, UCLA David Geffen School of Medicine|