Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds

Pharmanex

Status: Completed

Conditions: Healthy

Treatments: Other: Placebo; Dietary Supplement: Flavonoids+Prebiotics; Dietary Supplement: Flavonoids

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02871596

16-PHX-0003

Details and patient eligibility

About

The purpose of the study is to determine the effects of both an anthocyanin-rich polyphenol blend and an anthocyanin-rich polyphenol blend combined with a prebiotic blend on fecal microbiota metabolism (assessed by gas chromatograph - mass spectrometry (GC-MS) headspace analysis) and fecal microbiota composition (assessed by next generation sequencing).

Enrollment: 27 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female of any race or ethnicity between 18 to 70 years of age, inclusive;
• Body mass index (BMI) between 20 - 32 inclusive;
• Non-smoking status;
• Willing to consume assigned dietary supplements for a total of 6 weeks;
• Have access to email and a digital camera or camera phone.

Exclusion criteria

• Age <18 or >70 years;
• BMI <20 or >32;
• Uncontrolled hypertension defined as diastolic blood pressure ≥95 mm Hg or systolic blood pressure ≥160 mm Hg;
• Self-reported presence of atherosclerotic disease and/or cardiopulmonary disease;
• Renal, hepatic, endocrine, gastrointestinal or other systemic disease;
• For women, pregnancy, breast feeding or postpartum less than 6 months;
• Current participation in another research study;
• Allergy to the components in the dietary supplement (inulin, fructooligosaccharide, blueberries, black currant, rice);
• History of drug or alcohol abuse;
• Use of antibiotics within the last 6 months;
• Use of prebiotics or flavonoid-containing dietary supplements within the last 30 days;
• Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence;
• Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids;
• Participating in or planning to begin a weight loss diet during the study period;
• Lifestyle or schedule incompatible with the study protocol;
• Other medical, psychiatric, or behavioral conditions that in the view of the principal investigator may present a safety hazard to the participant or interfere with study participation or the ability to follow the intervention protocol;
• Use of tobacco products.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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27 participants in 6 patient groups

Placebo,Flavonoids,Flavonoids+Prebiotics

Experimental group

Description:

Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.

Treatment:

Dietary Supplement: Flavonoids+Prebiotics

Other: Placebo

Dietary Supplement: Flavonoids

Placebo,Flavonoids+Prebiotics,Flavonoids

Experimental group

Description:

Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.

Treatment:

Dietary Supplement: Flavonoids+Prebiotics

Other: Placebo

Dietary Supplement: Flavonoids

Flavonoids,Placebo,Flavonoids+Prebiotics

Experimental group

Description:

Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.

Treatment:

Dietary Supplement: Flavonoids+Prebiotics

Other: Placebo

Dietary Supplement: Flavonoids

Flavonoids,Flavonoids+Prebiotics,Placebo

Experimental group

Description:

Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.

Treatment:

Dietary Supplement: Flavonoids+Prebiotics

Other: Placebo

Dietary Supplement: Flavonoids

Flavonoids+Prebiotics,Placebo,Flavonoids

Experimental group

Description:

Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.

Treatment:

Dietary Supplement: Flavonoids+Prebiotics

Other: Placebo

Dietary Supplement: Flavonoids

Flavonoids+Prebiotics,Flavonoids,Placebo

Experimental group

Description:

Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.

Treatment:

Dietary Supplement: Flavonoids+Prebiotics

Other: Placebo

Dietary Supplement: Flavonoids