Effect of Spice Consumption on the Microbiome

NCT03676803 | Completed Results

• 1 other identifier: IRB#17-000617
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiota

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change From Baseline in Short-chain Fatty Acids (SCFAs) at 2 Weeks

  2 weeks

Study Arms (2)

Mixed spices intervention group

EXPERIMENTAL

healthy participants consume a capsule containing 5 g of mixed spices at culinary dose

Other: mixed spices

placebo group

PLACEBO COMPARATOR

healthy participants consume placebo capsule containing 5 g of maltodextrin

Other: placebo capsule containing 5 g of maltodextrin

Interventions

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.

Mixed spices intervention group

placebo capsule containing 5 g of maltodextrin OTHER

placebo capsule containing 5 g of maltodextrin

placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy human adults age 18-65 years old
• Typically consume low fiber/polyphenol diet (beige diet)-

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition, 900 Veteran Ave.

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

maltodextrin

Results Point of Contact

• Title: Zhaoping Li, MD, PhD
• Organization: UCLA Center for Human Nutrition

zli@medent.ucla.edu

310-206-1987

Study Officials

• Zhaoping Li, MD, PhD

  Center for Human Nutrition, UCLA David Geffen School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 19, 2018
• Study Start: August 3, 2017
• Primary Completion: November 17, 2017
• Study Completion: May 30, 2018
• Last Updated: November 19, 2019
• Results First Posted: November 19, 2019

Record last verified: 2019-11

Locations

US (1)