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Trial record 9 of 99 for:    grams | maltodextrin

Effect of Spice Consumption on the Microbiome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03676803
Recruitment Status : Completed
First Posted : September 19, 2018
Results First Posted : November 19, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

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.


Condition or disease Intervention/treatment Phase
Microbiota Other: mixed spices Other: placebo capsule containing 5 g of maltodextrin Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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United States, California
UCLA Center for Human Nutrition, 900 Veteran Ave.
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Zhaoping Li, MD, PhD Center for Human Nutrition, UCLA David Geffen School of Medicine
  Study Documents (Full-Text)

Documents provided by Zhaoping Li, University of California, Los Angeles:
Study Protocol  [PDF] August 11, 2017
Statistical Analysis Plan  [PDF] August 11, 2017


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Responsible Party: Zhaoping Li, Professor and Chief, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03676803    
Other Study ID Numbers: IRB#17-000617
First Posted: September 19, 2018    Key Record Dates
Results First Posted: November 19, 2019
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No