Effect of Spice Consumption on the Microbiome
Condition: Microbiota
Study type: Interventional

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.
    

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).
    

Intervention name(s): mixed spices; placebo capsule containing 5 g of maltodextrin
Intervention type(s): Other; Other
Intervention description(s): 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 maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other