ERr 731® Formulation Evaluation

NCT05959057 | Completed

• 1 other identifier: 2023-002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

A comparison of an enteric coated and micro-coated formulation of ERr 731®

Conditions

Menopause

Keywords

Botanical supplement; Formulation; Rhapontic Rhubarb

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal Tolerability

  Frequency of symptoms of gastrointestinal nature collected on a custom questionnaire

  14 days

Secondary Outcomes (1)

• General Tolerability

  14 Days

Study Arms (2)

Enteric/Micro Order

EXPERIMENTAL

Subjects will receive randomly two distinct formulations of ERr 731® in a 43 day trial consisting of treatment phase 1 (14-days), washout phase (14-days),treatment phase 2 (14-days): Arm 1 will receive enteric coated ERr 731® during treatment phase 1 and micro-coated ERr 731®during treatment phase 2

Dietary Supplement: ERr 731 - Micro-coated; Dietary Supplement: ERr 731 - Enteric coated

Micro/Enteric Order

EXPERIMENTAL

Subjects will receive randomly two distinct formulations of ERr 731® in a 43 day trial consisting of treatment phase 1 (14-days), washout phase (14-days),treatment phase 2 (14-days): Arm 2 will receive micro-coated ERr 731® during treatment phase 1 and enteric coated ERr 731®during treatment phase 2

Dietary Supplement: ERr 731 - Micro-coated; Dietary Supplement: ERr 731 - Enteric coated

Interventions

ERr 731 - Micro-coated DIETARY_SUPPLEMENT

natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.

Enteric/Micro Order; Micro/Enteric Order

ERr 731 - Enteric coated DIETARY_SUPPLEMENT

natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.

Also known as: Estrovera

Enteric/Micro Order; Micro/Enteric Order

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 35-64, inclusive, preference given to Subjects Ages 45-54, inclusive
• Preference given to symptomatic Subjects; symptoms including vasomotor symptoms, mood disturbances, fatigue, myalgias and arthralgias.

You may not qualify if:

• A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or oncological/hematologic disease.
• History of Breast or Uterine cancers.
• Known infection with HIV, Tuberculosis or Hepatitis B or C.
• Hormone Replacement Therapy: All formulations of synthetic estrogens, natural estrogens (estrone, estradiol and estriol) and progestins (including natural progesterone)
• Hormonal Contraceptives: All formulations of synthetic estrogens and progestins
• Botanical Formulations - including phytoestrogens and progesterone-mimetic botanicals (Rhapontic Rhubarb, Soy Phytoestrogens, Hops (8-prenyl naringin) Red Clover, Kudzu, Chaste Tree Berry, Licorice, Resveratrol, Black Cohosh, Dong Quai, etc.)
• Use of Narcotics during the last 30 days
• Use of Anticoagulants during last 30 days
• Use of Corticosteroids during the last 30 days
• Use of controlled substances (other than marijuana or CBD) on a recreational basis during the last 30 days.
• Consumption of more than 3 alcoholic beverages per day (One beverage is a 5-ounce glass of wine, 12 ounces of beer, or one ounce of hard liquor)
• Pregnancy
• Breast Feeding

Sponsors & Collaborators

• Metagenics, Inc.: lead

Study Sites (1)

Personalized Lifestyle Medicine Center

Gig Harbor, Washington, 98332, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded as to order formulations are received in a standard cross-over design with washout phase
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blinded, randomized cross-over design in a peri-menopausal/menopausal and preferably symptomatic group of women (target population for commercialization) is best suited to demonstrate equivalent tolerability

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: July 25, 2023
• Study Start: May 24, 2023
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)