EFE1: ERr 731® Formulation Evaluation

Sponsor

Metagenics, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05959057

Collaborator

(none)

Enrollment

Location

Arms

2.8

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Menopause	Dietary Supplement: ERr 731 - Micro-coated Dietary Supplement: ERr 731 - Enteric coated	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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 tolerabilitydouble-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

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Double-blinded as to order formulations are received in a standard cross-over design with washout phase

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 24, 2023

Anticipated Primary Completion Date :

Aug 18, 2023

Anticipated Study Completion Date :

Aug 18, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Gastrointestinal Tolerability [14 days]
Frequency of symptoms of gastrointestinal nature collected on a custom questionnaire

Secondary Outcome Measures

General Tolerability [14 Days]
Frequency of general symptoms collected on a custom questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 64 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Personalized Lifestyle Medicine Center	Gig Harbor	Washington	United States	98332

Sponsors and Collaborators

Metagenics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Metagenics, Inc.

ClinicalTrials.gov Identifier:

NCT05959057

Other Study ID Numbers:

2023-002

First Posted:

Jul 25, 2023

Last Update Posted:

Jul 25, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Metagenics, Inc.

Botanical supplement

Formulation

Rhapontic Rhubarb

Study Results

No Results Posted as of Jul 25, 2023