This is a randomized, 2-period crossover study aimed at assessing the effect of taking a food supplement containing a blend of microbial accessible carbohydrates on the diversity of the gut microbiome. Impacts to the skin, scalp and oral microbiomes; blood inflammatory biomarkers; quality and quantity of sleep; gastrointestinal quality of life; bowel habits, and facial skin features will also be evaluated.
The human body is home to trillions of microbes, which have been shown to play important roles in many aspects of human biology, such as immune function and metabolism. Research in this area has primarily focused on the role that dietary factors have in modulating the gastrointestinal (GI) microbiota with associated changes in host health parameters. Specifically, dietary microbiota accessible carbohydrates (MACs), which include compounds such as resistant starches and other dietary fibers that are typically resistant to digestion, have been shown to serve as a primary source of energy for the distal gut microbiota. Metabolism of MACs by the GI microbiota is important in shaping this microbial ecosystem. A Western diet, typically low in MAC content (e.g., dietary fiber), is associated with a marked reduction in microbial diversity and depletion of specific types of potentially beneficial microbes. Until only recently, the bulk of microbiota studies have been conducted in animals, and human studies on the GI microbiota have focused primarily on delineating the gut bacterial composition and corresponding changes in taxonomy in response to a particular dietary intervention (e.g., with prebiotics). Additionally, investigations on dietary factors influencing the skin (or scalp) and oral cavity microbiomes have only recently garnered attention. Human intervention studies that increase consumption of dietary MACs are needed to better understand how changes in the composition and function of these bacteria influence host parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
30
All subjects will have a dose-escalation period when randomized to the active arm that will occur as follows: Day 1: 1 scoop of product (morning, in the clinic) Day 2: 1 scoop of product (morning) Day 3: 2 scoops of product (morning and evening) Day 4: 2 scoops of product (morning and evening) Days 5-60: 3 scoops of product (morning, afternoon, evening) Other Names: Dietary fiber supplement
No Intervention for 8 weeks
Biofortis Innovation Services
Addison, Illinois, United States
Change from Baseline in Fecal Microbiome Shannon Diversity Index
The Shannon Diversity Index of the fecal microbiome will be measured at each of the time points via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing
Time frame: Baseline, 2, 4 and 8 Weeks
Change from Baseline in Fecal Microbiome Composition
The fecal microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing
Time frame: Baseline, 2, 4 and 8 Weeks
Change from Baseline in Forehead Skin Microbiome Composition
The forehead skin microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing
Time frame: Baseline, 2, 4 and 8 Weeks
Change from Baseline in Scalp Skin Microbiome Composition
The scalp skin microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing
Time frame: Baseline, 2, 4 and 8 Weeks
Change from Baseline in Oral (Buccal) Microbiome Composition
The oral microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing
Time frame: Baseline, 2, 4 and 8 Weeks
Change from Baseline in Fecal Short Chain Fatty Acids (Butyrate)
Fecal short chain fatty acids (e.g., butyrate) will be measured at each of the time points.
Time frame: Baseline, 2, 4 and 8 Weeks
Change from Baseline in Blood Inflammatory Marker (C-Reactive Protein)
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The inflammatory marker C-Reactive Protein in the blood will be measured at each of the time points.
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Blood Inflammatory Marker (IL-10)
The inflammatory marker IL-10 in the blood will be measured at each of the time points.
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Blood Inflammatory Marker (IL-6)
The inflammation marker IL-6 in the blood will be measured at each of the time points.
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Blood Inflammatory Marker (TNF-Alpha)
The inflammation marker TNF-alpha in the blood will be measured at each of the time points.
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Blood Inflammatory Marker (Lipopolysaccharides)
The inflammation marker lipopolysaccharides in the blood will be measured at each of the time points.
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Blood Testosterone Hormone Levels
Blood Testosterone Levels (free and total) will be measured at each of the time points.
Time frame: Baseline and 8 Weeks
Change from Baseline in Blood Estradiol Levels
Blood Estradiol Levels will be measured at each of the time points
Time frame: Baseline and 8 Weeks
Change from Baseline in Fasting Blood Lipid Profiles
Blood lipid profiles (including total cholesterol, HDL-cholesterol, non-HDL-cholesterol, calculated LDL-cholesterol, and triglycerides) will be measured at each of the time points
Time frame: Baseline and 8 Weeks
Change from Baseline in Satiety
An appetite questionnaire will be used to measure satiety at each of the time points
Time frame: Baseline, 2, 4 and 8 Weeks
Change from Baseline in Heart Rate Variance
Heart Rate Variance will be measured using a standardized method at each of the time points
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Bowel habits
Bowel habits will be recorded using a diary at each of the time points.
Time frame: Baseline, 2, 4 and 8 weeks
Change from Baseline in Stool Quality
Subjects will record the quality of their stool using the Bristol Stool Scale at each of the time points
Time frame: Baseline, 2, 4 and 8 Weeks
Change in Gastrointestinal Quality of Life (GIQOL)
The electronic GIQOL Instrument will be used to asses GI QoL at each of the time points.
Time frame: 4 and 8 Weeks
Change in Sleep Quantity
Each subject will wear an activity tracker (Actigraph) to measure the amount of sleep obtained from baseline to 8 weeks.
Time frame: Baseline through 8 Weeks
Change from Baseline in Sleep Quality
The electronic Pittsburgh Sleep Quality Index Instrument will be used to measure the change from baseline in Sleep Quality Index
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Facial Wrinkling
Standardized facial images will be captured using the VISIA CR facial imaging system under multiple lighting modalities. Images will be analyzed using quantitative image analysis to assess facial wrinkling around the eye (crow's feet wrinkles).
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Facial Hyperpigmentation
Standardized facial images will be captured using the VISIA CR facial imaging system under multiple lighting modalities. Images will be analyzed using quantitative image analysis to assess facial hyperpigmentation around the eyes and on the left and right cheeks.
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Facial Redness
Standardized facial images will be captured using the VISIA CR facial imaging system under multiple lighting modalities. Images will be analyzed using quantitative image analysis to assess facial red features on the left and right cheeks.
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Facial Porphyrins
Standardized facial images will be captured using the VISIA CR facial imaging system under multiple lighting modalities. Images will be analyzed using quantitative image analysis to assess facial porphyrins on the forehead, nose and on the left and right cheeks.
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Facial Skin Texture
Standardized facial images will be captured using the VISIA CR facial imaging system under multiple lighting modalities. Images will be analyzed using quantitative image analysis to assess facial skin texture on the left and right cheeks.
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Facial Skin Pores
Standardized facial images will be captured using the VISIA CR facial imaging system under multiple lighting modalities. Images will be analyzed using quantitative image analysis to assess facial skin pores on the left and right cheeks.
Time frame: Baseline, 4 and 8 Weeks
Beauty Quality of Life
The electronic Beauty Quality of Life Instrument will be used to measure BeautyQOL at 8 Weeks
Time frame: 8 Weeks
Test Product Likability
An electronic product likability questionnaire will be used to measure the subjects response to how much they liked the test product at 8 weeks. Product attributes will include flavor, sweetness, texture, thickness, and ease of consumption.
Time frame: 8 Weeks