Gut MicrobiomeNCT03058575
Effects of a Novel Food Product Containing Microbiota Accessible Carbohydrates on the Human Microbiome
A study testing Dietary MACs in people with Gut Microbiome, run by Access Business Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome
- What is being tested?
- Dietary MACs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2017to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Innovation Services
Addison, Illinois, 60101
About this study
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
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.
Read the 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.
- Conditions
- Gut Microbiome
- Being tested
- Dietary MACs, Control
- Keywords
- Microbiome, Gut, Skin, Fiber, Starch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary MACsDietary 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
ControlOther
No Intervention for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Dietary MACs |
| Control | Other | No Intervention Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 2, 4 and 8 Weeks
Secondary outcomes (28)
Change from Baseline in Fecal Microbiome Composition
The fecal microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline, 2, 4 and 8 Weeks
Change from Baseline in Blood Inflammatory Marker (C-Reactive Protein)
The inflammatory marker C-Reactive Protein in the blood will be measured at each of the time points.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 Weeks
Change from Baseline in Blood Estradiol Levels
Blood Estradiol Levels will be measured at each of the time points
Measured: 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
Measured: Baseline and 8 Weeks
Change from Baseline in Satiety
An appetite questionnaire will be used to measure satiety at each of the time points
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start16 Jan 2017
- Primary completion11 Jul 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, 2-period crossover study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access Business Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Lawless, MD, Principal investigator, Biofortis Innovation Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058575
- Sponsor's protocol ID
- BIO-1611
- Status last verified
- Jan 2018
- First submitted
- 24 Jan 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23165832De 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.
PubMed 20679230El 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.
PubMed 23748339Eypasch 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.
PubMed 7749697Hooper 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.
PubMed 22674334Karlsson 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.
PubMed 24065795McGill 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.
PubMed 25671414Sonnenburg 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.
PubMed 25156449
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03058575
- Acronym / sponsor ID
- BIO-1611
- Conditions
- Gut Microbiome
- Keywords
- Microbiome, Gut, Skin, Fiber, Starch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Access Business GroupIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 11 Jul 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, 2-period crossover study.
| Arm | Type | Receives |
|---|---|---|
| Dietary MACs | Experimental | Dietary Supplement: Dietary MACsDietary 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. |
| Control | Other | Other: ControlNo Intervention |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary MACsAll 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 supplement | Dietary MACs |
| ControlNo Intervention for 8 weeks | Other | Control |
Primary outcome
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
28 secondary outcomes
Change from Baseline in Fecal Microbiome Composition
Time frame: Baseline, 2, 4 and 8 Weeks
Change from Baseline in Forehead Skin Microbiome Composition
Time frame: Baseline, 2, 4 and 8 Weeks
Change from Baseline in Scalp Skin Microbiome Composition
Time frame: Baseline, 2, 4 and 8 Weeks
Change from Baseline in Oral (Buccal) Microbiome Composition
Time frame: Baseline, 2, 4 and 8 Weeks
Change from Baseline in Fecal Short Chain Fatty Acids (Butyrate)
Time frame: Baseline, 2, 4 and 8 Weeks
Change from Baseline in Blood Inflammatory Marker (C-Reactive Protein)
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Blood Inflammatory Marker (IL-10)
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Blood Inflammatory Marker (IL-6)
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Blood Inflammatory Marker (TNF-Alpha)
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Blood Inflammatory Marker (Lipopolysaccharides)
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Blood Testosterone Hormone Levels
Time frame: Baseline and 8 Weeks
Change from Baseline in Blood Estradiol Levels
Time frame: Baseline and 8 Weeks
Change from Baseline in Fasting Blood Lipid Profiles
Time frame: Baseline and 8 Weeks
Change from Baseline in Satiety
Time frame: Baseline, 2, 4 and 8 Weeks
Change from Baseline in Heart Rate Variance
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Bowel habits
Time frame: Baseline, 2, 4 and 8 weeks
Change from Baseline in Stool Quality
Time frame: Baseline, 2, 4 and 8 Weeks
Change in Gastrointestinal Quality of Life (GIQOL)
Time frame: 4 and 8 Weeks
Change in Sleep Quantity
Time frame: Baseline through 8 Weeks
Change from Baseline in Sleep Quality
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Facial Wrinkling
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Facial Hyperpigmentation
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Facial Redness
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Facial Porphyrins
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Facial Skin Texture
Time frame: Baseline, 4 and 8 Weeks
Change from Baseline in Facial Skin Pores
Time frame: Baseline, 4 and 8 Weeks
Beauty Quality of Life
Time frame: 8 Weeks
Test Product Likability
Time frame: 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Background: PubMed 23165832Beresniak 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.
- Background: PubMed 20679230De 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.
- Background: PubMed 23748339El 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.
- Background: PubMed 7749697Eypasch 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.
- Background: PubMed 22674334Hooper 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.
- Background: PubMed 24065795Karlsson 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.
- Background: PubMed 25671414McGill 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.
- Background: PubMed 25156449Sonnenburg 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.
- Individual participant dataSharing planned: No
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Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Recruiting
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Lawless, MD principal investigator
Biofortis Innovation Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary MACs in people with Gut Microbiome, run by Access Business Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Fecal Microbiome Shannon Diversity Index (time frame: Baseline, 2, 4 and 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03058575, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.