Flavonoid-rich Supplement Influence on the Human Metabolome

NCT03004742 | Completed

• 1 other identifier: 15-0274
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study will measure the effect of ingesting a flavonoid-rich supplement on various biomarkers in overweight/obese women during a 12-week period. The flavonoid-rich supplement contains a mixture of flavonoids including quercetin, catechins from green tea extract, and anthocyanins from bilberry extract, and other food components that facilitate flavonoid bioactivity including fish oil, caffeine, and vitamin C.

Conditions

Inflammation

Keywords

polyphenols; metabolomics; oxidative stress

Outcome Measures

Primary Outcomes (1)

• Change in Urine phenolics

  24-h urine samples collected pre-study and after 12-weeks intervention

  Change from baseline urine phenolics at 12 weeks

Secondary Outcomes (8)

• Change in global metabolomics

  Change from baseline global metabolomics at 12 weeks

• Change in symptoms

  Change from baseline symptoms at 4-weeks, 8-weeks, 12-weeks.

• Change in oxidized LDL

  Change from baseline oxidized LDL at 12 weeks

• Change in blood diagnostic chemistries

  Change from baseline diagnostic chemistries at 12 weeks

• Change in CRP

  Change from baseline CRP at 12 weeks

Study Arms (2)

Flavonoid

EXPERIMENTAL

Flavonoid supplement

Dietary Supplement: Flavonoid

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Flavonoid DIETARY_SUPPLEMENT

Flavonoid rich supplement

Flavonoid

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 25 kg/m2 and higher (about 25 pounds or more overweight from recommended levels)
• Generally healthy and without chronic disease including cardiovascular disease (e.g., heart disease, stroke), cancer, type 1 diabetes, rheumatoid arthritis
• Willingness to maintain normal physical activity and diet habits, and make no formal attempts to lose weight during the 12-week study.

You may not qualify if:

• Use of Aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) within the past one to two weeks, and plans to use NSAIDs during the 12-week period of the study. Examples include ibuprofen (Advil, Motrin, Nuprin), naproxen (Aleve, Naprosyn), and COX-2 inhibitors (Celebrex).
• Regular use of fish oil supplements, omega 3 supplements, or omega 3-based drugs (Lovaza, etc.) during the past one to two weeks and plans to use these supplements during the study.
• History of allergy or intolerance to green tea, blueberries, fish oil, caffeine, or the flavonoid quercetin.
• Pregnant or breastfeeding
• Currently on a weight reducing plan or using weight-loss medications (e.g., selective serotonin reuptake inhibitors, steroids, Ritalin, appetite suppressors, Xenical, Diethylpropion), and plans to continue during the 12-week period of the study.
• Regular use of large dose nutrient, herbal, and dietary supplements during the past one to two weeks, and plans to use these during the 12-week period of the study.

Sponsors & Collaborators

• Appalachian State University: lead
• Reoxcyn Discoveries Group: collaborator

Study Sites (1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Flavonoids

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• David C Nieman, DrPH

  Appalachian State Univ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 29, 2016
• Study Start: August 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 2, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)