Effects of a Novel Food Product Containing Microbiota Accessible Carbohydrates on the Human Microbiome

NCT03058575 | Completed

• 1 other identifier: BIO-1611
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiome

Keywords

Microbiome; Gut; Skin; Fiber; Starch

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 2, 4 and 8 Weeks

Secondary Outcomes (28)

• Change from Baseline in Fecal Microbiome Composition

  Baseline, 2, 4 and 8 Weeks

• Change from Baseline in Forehead Skin Microbiome Composition

  Baseline, 2, 4 and 8 Weeks

• Change from Baseline in Scalp Skin 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

Study Arms (2)

Dietary MACs

EXPERIMENTAL

Dietary fiber supplement (blend of resistant starch and dietary fiber food ingredients providing 15g of microbiota accessible carbohydrate/1 scoop serving) will be provided in a powder that will be mixed with 6-10 oz of water (depending on desired thickness) and consumed as a chocolate shake.

Dietary Supplement: Dietary MACs

Control

OTHER

No Intervention

Other: Control

Interventions

Dietary MACs DIETARY_SUPPLEMENT

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

Dietary MACs

Control OTHER

No Intervention for 8 weeks

Control

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Access Business Group: lead

Study Sites (1)

Biofortis Innovation Services

Addison, Illinois, 60101, United States

Location

Related Publications (8)

• Beresniak A, de Linares Y, Krueger GG, Talarico S, Tsutani K, Duru G, Berger G. Validation of a new international quality-of-life instrument specific to cosmetics and physical appearance: BeautyQoL questionnaire. Arch Dermatol. 2012 Nov;148(11):1275-82. doi: 10.1001/archdermatol.2012.2696.

  PMID: 23165832 BACKGROUND

• De Filippo C, Cavalieri D, Di Paola M, Ramazzotti M, Poullet JB, Massart S, Collini S, Pieraccini G, Lionetti P. Impact of diet in shaping gut microbiota revealed by a comparative study in children from Europe and rural Africa. Proc Natl Acad Sci U S A. 2010 Aug 17;107(33):14691-6. doi: 10.1073/pnas.1005963107. Epub 2010 Aug 2.

  PMID: 20679230 BACKGROUND

• El Kaoutari A, Armougom F, Gordon JI, Raoult D, Henrissat B. The abundance and variety of carbohydrate-active enzymes in the human gut microbiota. Nat Rev Microbiol. 2013 Jul;11(7):497-504. doi: 10.1038/nrmicro3050. Epub 2013 Jun 10.

  PMID: 23748339 BACKGROUND

• Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.

  PMID: 7749697 BACKGROUND

• Hooper LV, Littman DR, Macpherson AJ. Interactions between the microbiota and the immune system. Science. 2012 Jun 8;336(6086):1268-73. doi: 10.1126/science.1223490. Epub 2012 Jun 6.

  PMID: 22674334 BACKGROUND

• Karlsson F, Tremaroli V, Nielsen J, Backhed F. Assessing the human gut microbiota in metabolic diseases. Diabetes. 2013 Oct;62(10):3341-9. doi: 10.2337/db13-0844.

  PMID: 24065795 BACKGROUND

• 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.

  PMID: 25671414 BACKGROUND

• 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.

  PMID: 25156449 BACKGROUND

Study Officials

• Andrea Lawless, MD

  Biofortis Innovation Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessors will be blind to who is on Arm1 and who is on Arm 2.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, 2-period crossover study.

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 23, 2017
• Study Start: January 16, 2017
• Primary Completion: July 11, 2017
• Study Completion: September 30, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)