Sunfiber and the Microbiota

Study Overview
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Brief Summary
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The aim of this study is to look at the effect Sunfiber has on the gut microbiota.

Detailed Description
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This is a randomized, double-blind, placebo-controlled crossover study with a 2 week washout period. Healthy volunteers will receive placebo, 4 grams, or 8 grams of Sunfiber in addition to their regular diet. Fecal samples will be collected for measurement of bowl function, including the gut microbiota.

Official Title
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Sunfiber and the Microbiota

Conditions
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Diet Modification

Intervention / Treatment
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* Dietary Supplement: Low fiber
* Dietary Supplement: Placebo
* Dietary Supplement: High fiber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Healthy male or female between the ages of 20-49 years Subject has a body mass index of ≥18.5 and ≤30 kg/m2 at screening visit. Subject is willing to stick to their normal habitual diet excluding the consumption of any unusual high energy-rich or fat-rich meals or prolonged fasting, etc. through the study period. Subject is willing to maintain their habitual physical activity patterns throughout the study period. Subject has been weight stable within the last 6 months. Subject has no health conditions that would prevent him or her from fulfilling the study requirements as judged by the investigator on the basis of medical history and routine laboratory test results. Low fiber consumer (≤14 g per day) Subject is willing to follow study procedures and dietary restrictions (ex: stick to habitual diet, refrain from consuming alcohol 24 hours prior to test days). Subject understands study procedures and signs forms providing informed consent to participate in the study. Exclusion Criteria: History of a gastrointestinal disorder Lactose intolerant High fiber consumer (≥15 g per day) Use of pre-and probiotics in the past 90 days High protein consumer (i.e. vegetarians or those who follow diets high in protein such as paleo) History of psychological illness or conditions that may interfere with subjects ability to understand study directions Use of antibiotics or signs of active systemic infection in the last 6 months. Subjects who are on hypo/hypercaloric diet aiming for weight loss or weight gain History or presence of cancer in the prior 2 years (except for non-melanoma skin cancer). Currently pregnant, lactating or planning to be pregnant during the study period Regular use of dietary supplements (ex: fish oil, riboflavin, etc.), 90 days prior to study inclusion Exposure to any non-registered drug product within the last 30 days prior to screening visit History of or strong potential for alcohol or substance abuse (within 12 months of screening visit). Alcohol abuse is defined as >60g (men)/40g (women) pure alcohol per day (1.5 L/ 1 l beer resp. 0.75l/0.5l wine).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 3 arm crossover, randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Arm<br>Healthy volunteers will continue normal healthy diet with a placebo. | Dietary Supplement: Placebo<br>* Participants will receive the placebo/dextrose.<br>|
| Experimental: Low fiber<br>Healthy volunteers will be randomized to receive 3 grams of Sunfiber. | Dietary Supplement: Low fiber<br>* Partially hydrolyzed guar gum (PHGG) commercially available as Sunfiber in 3 gram doses<br>|
| Experimental: High fiber<br>Healthy volunteers will be randomized to receive 6 grams of Sunfiber. | Dietary Supplement: High fiber<br>* Partially hydrolyzed guar gum (PHGG) commercially available as Sunfiber in 6 gram doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of Microbiota | Bacterial phyla, genera, and species of bacteria will be detected using real tijme PCR. All abundances will be calculated and presented as relative levels (relative to the total amount of eubacteriausing a universal eubacteria prijer set) | Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| salivary cortisol | Salivary cortisol will be measured using a competitive immunoassay. 25 ul of saliva will be used in each replicate and results will be compared to a standard curve and calculated as ug/dl. | Day 10 |