ERr 731® Formulation Evaluation (EFE1)

ERr 731® Formulation Evaluation: A Comparison of Enteric Coated and Micro-coated ERr 731® Formulations

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

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Dietary supplement: ERr 731 - Micro-coated; Dietary supplement: ERr 731 - Enteric coated

Detailed Description

Current clinical and commercialization experiences have been with enteric-coated formulations of ERr 731®. With the demonstrated safety of this formulation and the absence of anthraquinones in the extract, there is interest in launching a micro-coated, but not enteric-coated, formulation to broaden the commercial availability of ERr 731® in new markets. It is proposed that a 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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Gig Harbor, Washington, United States, 98332
      • Personalized Lifestyle Medicine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enteric/Micro Order; 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; natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.; Dietary supplement: ERr 731 - Enteric coated; natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.; Other Names: Estrovera
Experimental: Micro/Enteric Order; 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; natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.; Dietary supplement: ERr 731 - Enteric coated; natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.; Other Names: Estrovera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Tolerability	Frequency of symptoms of gastrointestinal nature collected on a custom questionnaire	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Tolerability	Frequency of general symptoms collected on a custom questionnaire	14 Days

Collaborators and Investigators

• Sponsor: Metagenics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Actual): August 18, 2023
• Study Completion (Actual): August 18, 2023

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: July 15, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Formulation; Botanical supplement; Rhapontic Rhubarb
• Other Study ID Numbers: 2023-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No