A Randomized, Controlled, Crossover Study to Evaluate the Effects of a Novel Food Product Containing Microbiota Accessible Carbohydrates on the Human Microbiome and Associated Parameters
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gut Microbiome
- Sponsor
- Access Business Group
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Fecal Microbiome Shannon Diversity Index
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is male or female, 40-60 years of age, inclusive.
- •Subject has a waist circumference ≥102 cm (40 inches) in men or ≥89 cm (35 inches) in women at visit 1a (week -1).
- •Subject does not smoke or use any products containing nicotine (including use of any tobacco products) for the past 6 months prior to Visit 1b and has no plans to change smoking habits during the study period.
- •For males, subject is willing to shave prior to facial imaging test days (total of 6 clinic visits).
- •Subject is willing and able to comply with the visit schedule and fecal sample collection requirements (a total of 8 fecal samples) during the study period.
- •Subject does not plan to willingly change his or her habitual diet, physical activity patterns, or body weight during the study period.
- •Subject is willing and able to consume a low-calorie, 6-10 oz chocolate shake, as directed, for 8 weeks.
- •Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
- •Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion Criteria
- •Subject has abnormal laboratory test results of clinical significance at Visit 1b (week -1), at the discretion of the Investigator. One re-test will be allowed on a separate day prior to Visit 2 (week 0), for subjects with abnormal laboratory test results.
- •Subject has a history or presence of clinically important endocrine (including hyperparathyroidism, type 1 or 2 diabetes mellitus and/or hypoglycemia), cardiovascular (including, but not limited to history of myocardial infarction, peripheral arterial disease, stroke), pulmonary (including uncontrolled asthma), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, rheumatic (including gout), biliary, and/or psychiatric disorders, that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
- •Subject has had a recent (within 2 weeks of Visit 1b; week -1) episode of acute GI illness such as nausea/vomiting or diarrhea.
- •Subject has a history or presence of a diagnosed GI disease, including but not limited to, irritable bowel syndrome, inflammatory bowel disease, Celiac disease, or Crohn's disease.
- •Subject has a recent history (within 6 weeks of Visit 1b, week -1) of constipation (defined as \<3 bowel movements per week).
- •Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
- •Subject has a history of bariatric surgery for weight reducing purposes.
- •Subject has extreme dietary habits, including but not limited to, intentional consumption of a high fiber diet, and/or vegan/other vegetarian diets, in the opinion of the Investigator.
- •Subject has had a weight loss or gain \>4.5 kg in the 6 months prior to Visit 1b (week -1).
- •Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at Visit 1b (week -1). One re-test will be allowed on a separate day prior to Visit 2 (week 0), for subjects whose blood pressure exceeds either of these cut points, in the judgment of the Investigator.
Outcomes
Primary Outcomes
Change from Baseline in Fecal Microbiome Shannon Diversity Index
Time Frame: Baseline, 2, 4 and 8 Weeks
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
Secondary Outcomes
- Change from Baseline in Blood Inflammatory Marker (C-Reactive Protein)(Baseline, 4 and 8 Weeks)
- Change from Baseline in Forehead Skin Microbiome Composition(Baseline, 2, 4 and 8 Weeks)
- Change from Baseline in Blood Inflammatory Marker (Lipopolysaccharides)(Baseline, 4 and 8 Weeks)
- Change from Baseline in Fasting Blood Lipid Profiles(Baseline and 8 Weeks)
- Change from Baseline in Satiety(Baseline, 2, 4 and 8 Weeks)
- Change from Baseline in Facial Porphyrins(Baseline, 4 and 8 Weeks)
- Test Product Likability(8 Weeks)
- Change from Baseline in Scalp Skin Microbiome Composition(Baseline, 2, 4 and 8 Weeks)
- Change from Baseline in Blood Inflammatory Marker (TNF-Alpha)(Baseline, 4 and 8 Weeks)
- Change from Baseline in Blood Testosterone Hormone Levels(Baseline and 8 Weeks)
- Change from Baseline in Blood Estradiol Levels(Baseline and 8 Weeks)
- Change from Baseline in Heart Rate Variance(Baseline, 4 and 8 Weeks)
- Change from Baseline in Stool Quality(Baseline, 2, 4 and 8 Weeks)
- Change in Sleep Quantity(Baseline through 8 Weeks)
- Change from Baseline in Sleep Quality(Baseline, 4 and 8 Weeks)
- Change from Baseline in Facial Wrinkling(Baseline, 4 and 8 Weeks)
- Change from Baseline in Fecal Microbiome Composition(Baseline, 2, 4 and 8 Weeks)
- Change from Baseline in Oral (Buccal) Microbiome Composition(Baseline, 2, 4 and 8 Weeks)
- Change from Baseline in Fecal Short Chain Fatty Acids (Butyrate)(Baseline, 2, 4 and 8 Weeks)
- Change from Baseline in Blood Inflammatory Marker (IL-10)(Baseline, 4 and 8 Weeks)
- Change from Baseline in Blood Inflammatory Marker (IL-6)(Baseline, 4 and 8 Weeks)
- Change from Baseline in Bowel habits(Baseline, 2, 4 and 8 weeks)
- Change from Baseline in Facial Skin Texture(Baseline, 4 and 8 Weeks)
- Change from Baseline in Facial Skin Pores(Baseline, 4 and 8 Weeks)
- Change in Gastrointestinal Quality of Life (GIQOL)(4 and 8 Weeks)
- Change from Baseline in Facial Redness(Baseline, 4 and 8 Weeks)
- Change from Baseline in Facial Hyperpigmentation(Baseline, 4 and 8 Weeks)
- Beauty Quality of Life(8 Weeks)