Clinical trial NCT03058575: Effects of a Novel Food Product Containing Microbiota Accessible Carbohydrates on the Human Microbiome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Microbiome
Keywords: Microbiome
Gut
Skin
Fiber
Starch
Lead sponsor: Access Business Group
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized, 2-period crossover study.
Primary purpose: BASIC_SCIENCE

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.

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.
* Subject has used any antibiotics within 3 months of Visit 2 (week 0).
* Subject has used medications (over-the-counter or prescription) and/or dietary supplements, known to influence GI function, including but not limited to prebiotics or probiotics, laxatives, enemas, fiber supplements, suppositories, anti-diarrheal agents, and/or anti-spasmodics within 2 weeks of Visit 2 (week 0).
* Subject uses non-steroidal, anti-inflammatory drugs on a daily basis.
* Subject uses antacids, proton pump inhibitors, or histamine blockers on a daily basis within 1 week of Visit 2 (week 0).
* Subject has started lipid lowering prescription medication(s) within 4 weeks of Visit 2 (week 0). Subjects must be on a stable dose (defined as consistent dose) for at least 4 weeks prior to Visit 2 (week 0) and throughout the study period.
* Subject has a known allergy or sensitivity to any component or ingredient in the study product.
* Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
* Subject is a premenopausal female using a form of contraception that does not result in a normal menstrual cycle (normal cycle defined as a 21 to 35 d).
* Subject has a recent history of (within 1 month of Visit 1b) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week or more than 4 drinks at any one time (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
* Subject has been exposed to any non-registered drug product within 30 d prior to Visit 1b (week -1).
* Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.

Primary outcomes:
measure: Change from Baseline in Fecal Microbiome Shannon Diversity Index
timeFrame: Baseline, 2, 4 and 8 Weeks
Secondary outcomes:
measure: Change from Baseline in Fecal Microbiome Composition
timeFrame: Baseline, 2, 4 and 8 Weeks
measure: Change from Baseline in Forehead Skin Microbiome Composition
timeFrame: Baseline, 2, 4 and 8 Weeks
measure: Change from Baseline in Scalp Skin Microbiome Composition
timeFrame: Baseline, 2, 4 and 8 Weeks
measure: Change from Baseline in Oral (Buccal) Microbiome Composition
timeFrame: Baseline, 2, 4 and 8 Weeks
measure: Change from Baseline in Fecal Short Chain Fatty Acids (Butyrate)
timeFrame: Baseline, 2, 4 and 8 Weeks
measure: Change from Baseline in Blood Inflammatory Marker (C-Reactive Protein)
timeFrame: Baseline, 4 and 8 Weeks
measure: Change from Baseline in Blood Inflammatory Marker (IL-10)
timeFrame: Baseline, 4 and 8 Weeks
measure: Change from Baseline in Blood Inflammatory Marker (IL-6)
timeFrame: Baseline, 4 and 8 Weeks
measure: Change from Baseline in Blood Inflammatory Marker (TNF-Alpha)
timeFrame: Baseline, 4 and 8 Weeks
measure: Change from Baseline in Blood Inflammatory Marker (Lipopolysaccharides)
timeFrame: Baseline, 4 and 8 Weeks
measure: Change from Baseline in Blood Testosterone Hormone Levels
timeFrame: Baseline and 8 Weeks
measure: Change from Baseline in Blood Estradiol Levels
timeFrame: Baseline and 8 Weeks
measure: Change from Baseline in Fasting Blood Lipid Profiles
timeFrame: Baseline and 8 Weeks
measure: Change from Baseline in Satiety
timeFrame: Baseline, 2, 4 and 8 Weeks
measure: Change from Baseline in Heart Rate Variance
timeFrame: Baseline, 4 and 8 Weeks
measure: Change from Baseline in Bowel habits
timeFrame: Baseline, 2, 4 and 8 weeks
measure: Change from Baseline in Stool Quality
timeFrame: Baseline, 2, 4 and 8 Weeks
measure: Change in Gastrointestinal Quality of Life (GIQOL)
timeFrame: 4 and 8 Weeks
measure: Change in Sleep Quantity
timeFrame: Baseline through 8 Weeks
measure: Change from Baseline in Sleep Quality
timeFrame: Baseline, 4 and 8 Weeks
measure: Change from Baseline in Facial Wrinkling
timeFrame: Baseline, 4 and 8 Weeks
measure: Change from Baseline in Facial Hyperpigmentation
timeFrame: Baseline, 4 and 8 Weeks
measure: Change from Baseline in Facial Redness
timeFrame: Baseline, 4 and 8 Weeks
measure: Change from Baseline in Facial Porphyrins
timeFrame: Baseline, 4 and 8 Weeks
measure: Change from Baseline in Facial Skin Texture
timeFrame: Baseline, 4 and 8 Weeks
measure: Change from Baseline in Facial Skin Pores
timeFrame: Baseline, 4 and 8 Weeks
measure: Beauty Quality of Life
timeFrame: 8 Weeks
measure: Test Product Likability
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Addison
country: United States
facility: Biofortis Innovation Services
state: Illinois
Study officials:
affiliation: Biofortis Innovation Research
name: Andrea Lawless, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: McGill CR, Fulgoni VL 3rd, Devareddy L. Ten-year trends in fiber and whole grain intakes and food sources for the United States population: National Health and Nutrition Examination Survey 2001-2010. Nutrients. 2015 Feb 9;7(2):1119-30. doi: 10.3390/nu7021119.
citation: Sonnenburg ED, Sonnenburg JL. Starving our microbial self: the deleterious consequences of a diet deficient in microbiota-accessible carbohydrates. Cell Metab. 2014 Nov 4;20(5):779-786. doi: 10.1016/j.cmet.2014.07.003. Epub 2014 Aug 21.