Broccoli Seed Extract and Skin Health

NCT05745636 | Completed

• 1 other identifier: HS-22-42
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to examine the influence of 4-weeks ingestion of TrueBroc®, (broccoli seed extract, BSE) with mustard seed powder (MSP) on improving skin health by evaluating skin physiological and biochemical parameters. This study will test the effect of BSE and MSP compared to placebo on skin health after 4 weeks supplementation. The study will employ a randomized, crossover design with subjects acting as their own controls.

Conditions

Skin Inflammation

Keywords

broccoli; Glucoraphanin; inflammation; skin; sulforaphane (

Outcome Measures

Primary Outcomes (1)

• Skin IL-1beta (pg/ml)

  Skin inflammation cytokine

  Change from pre-study to post-4 weeks supplementation

Secondary Outcomes (6)

• Skin elasticity (arbitrary units)

  Change from pre-study to post-4 weeks supplementation

• Skin pH (arbitrary units)

  Change from pre-study to post-4 weeks supplementation

• Skin hydration (arbitrary units)

  Change from pre-study to post-4 weeks supplementation

• Skin pigmentation (melatonin content, no units)

  Change from pre-study to post-4 weeks supplementation

• Transepidermal water loss (TEWL) (g/m2/h)

  Change from pre-study to post-4 weeks supplementation

Study Arms (2)

Broccoli, mustard, vitamin C

EXPERIMENTAL

770 mg Broccoli Seed Extract (BSE) with 290 mg mustard seed powder (MSP) and 200 mg vitamin C

Dietary Supplement: Broccoli, mustard, vitamin C

Placebo

PLACEBO COMPARATOR

inactive excipients including microcrystalline cellulose, rice hull, maltodextrin, ascorbyl palmitate and silicon dioxide

Dietary Supplement: Placebo

Interventions

Broccoli, mustard, vitamin C DIETARY_SUPPLEMENT

2 capsules per day for 4 weeks

Broccoli, mustard, vitamin C

Placebo DIETARY_SUPPLEMENT

2 capsules per day for 4 weeks.

Placebo

Eligibility Criteria

• Age: 25 Years - 57 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both male and female subjects will be included, ages 25 to 57 years.
• Non-smoker and free of any medical conditions that might affect study measurements.
• Body mass index (BMI) of 20 - 29.9 kg/m2 (not obese).
• Willingness to adhere to dietary restrictions: refrain from consuming cruciferous vegetables (or related condiments and supplements) such as broccoli, cauliflower, cabbage, kale, bok choy, arugula, Brussels sprouts, collards, watercress, radishes, prepared mustard condiment, mustard greens, horseradish, wasabi, and mayonnaise for 3 days before and for the duration of the study.
• Willing to collect all urine for 24 hours and provide four blood samples on four separate occasions.

You may not qualify if:

• Diarrhea or oral antibiotic intake within the last 4 weeks.
• Use of proton pump inhibitors (PPIs), antacids or other medications that influence stomach acidity.
• History of malabsorption or GI tract disorders or GI surgeries (i.e. lapband, gastric bypass, etc.).
• History of allergic reactions or intolerance to any of the ingredients contained in the test supplements (e.g. broccoli, broccoli seeds, mustard seeds, vitamin C).
• Currently pregnant, planning to become pregnant, or breastfeeding.
• Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.

Sponsors & Collaborators

• Appalachian State University: lead
• North Carolina State University: collaborator

Study Sites (1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Dermatitis; Inflammation

Interventions

Amines; Ascorbic Acid

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organic Chemicals; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Officials

• Camila A Olson, PhD

  Appalachian State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Experimental and placebo capsules (2 consumed per day for 4 weeks) will look identical. Both the investigators and the subjects will be blinded, with the code held by the sponsor until the study and data analysis have been completed.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blinded, placebo-controlled, crossover design with 4-week supplementation periods and a 2-week washout period.

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: March 13, 2023
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-06

Locations

US (1)