The Effects of Geranylgeraniol (GG) Sourced From Annatto on Sexual Health

NCT05258513 | Completed

• 1 other identifier: 122102
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study will be to examine the effectiveness of Geranylgeraniol supplementation on sexual health function in males and females following an 8-week dose escalation intervention. The study will be carried out in a randomized, double-blind, placebo-controlled, parallel manner. Participants will be stratified into quartiles based on their scores on the Derogatis Interview for Sexual Functioning during screening and prior to baseline testing. Participants from each quartile will be randomly divided by into treatment or placebo conditions. Following randomization, participants will be baseline assessed on their sexual health function using a variety of questionnaires, body composition using a whole body Dual Energy X-Ray Absorptiometry scan, blood chemistry panel, and grip strength using a hand-held dynamometer. Following baseline testing, participants will undergo 8 weeks of supplementation of their respective supplement condition. Participants will be instructed to consume two servings a day (150mg total per day) from weeks 1-4. Subject will return to the study site after 4 weeks to reassess the above-mentioned parameters. Participants will then undergo a dose escalation and be instructed to consume two servings a day (300mg total per day) from week 5-8. Sexual health questionnaires and assessments of body composition, blood chemistry, and grip strength will be conducted following the week 8 to conclude the study.

Conditions

Sexual Health; Libido

Keywords

Sexual Health; Libido; Body Composition; Strength; Vitality; Hormones

Outcome Measures

Primary Outcomes (9)

• Changes in Overall Sexual Function

  Assessed by administering the Derogatis Interview for Sexual Functioning (DISF-SR) for subjective measurement. Values range from 0 to 8 with higher scores demonstrating a better outcome.

  Week 0, 4 and 8

• Changes in Aging Male Symptoms

  Assessed by administering the Aging Male Symptoms scale to males for subjective measurement. Values range from 1 to 5 with lower scores demonstrating a better outcome.

  Week 0, 4, and 8

• Changes in Androgen Deficiency in Aging Males Scale

  Assessed by administering the Androgen Deficiency in Aging Males scale to males for subjective measurement. Values range from 1 to 5 with higher scores demonstrating a better outcome.

  Week 0, 4, and 8

• Changes in Satisfaction to Treatment

  Assessed by administering the Erectile Dysfunction Interview for Treatment Satisfaction (EDITS) to males for subjective measurement. Values range from 0 to 4 with lower scores demonstrating a better outcome.

  Week 4 and 8

• Changes in Erection Hardness

  Assessed by administering the Erection Hardness Score (EHS) to males for subjective measurement. Values range from 0 to 4 with higher scores demonstrating a better outcome.

  Week 0, 4 and 8

• Changes in Erectile Function

  Assessed by administering the International Index of Erectile Function (IIEF) to males for subjective measurement. Values range from 0 to 5 with higher scores demonstrating a better outcome.

  Week 0, 4 and 8

• Changes in Female Sexual Function

  Assessed by administering the Female Sexual Function Index to females for subjective measurement. Values range from 0 to 5 with higher scores demonstrating a better outcome.

  Week 0, 4 and 8

• Changes in Hot Flashes

  Assessed by administering the Hot Flashes and Night Sweats questionnaire to females for subjective measurement. Values range from 0 to 10 with lower scores demonstrating a better outcome.

  Week 0, 4 and 8

• Changes in Night Sweats

  Assessed by administering the Hot Flashes and Night Sweats questionnaire to females for subjective measurement. Values range from 0 to 10 with lower scores demonstrating a better outcome.

  Week 0, 4 and 8

Secondary Outcomes (57)

• Testosterone

  Week 0, 4, and 8

• Estradiol

  Week 0, 4, and 8

• Progesterone

  Week 0, 4, and 8

• Sex Hormone Binding Globulin (SHBG)

  Week 0, 4, and 8

• Changes in Dihydrotestosterone (DHT)

  Week 0, 4, and 8

Other Outcomes (3)

• Resting Systolic Blood Pressure

  Week 0, 4, and 8

• Resting Diastolic Blood Pressure

  Week 0, 4, and 8

• Adverse Effects

  Week 0, 4, and 8

Study Arms (2)

Placebo

PLACEBO COMPARATOR

From weeks 1-4, participants will consume 150mg daily of a visually identical placebo. For weeks 5-8, the dose will be escalated as participants will consume 300mg daily of placebo supplementation.

Dietary Supplement: Placebo Supplementation

Geranylgeraniol Treatment

EXPERIMENTAL

From weeks 1-4, participants will consume 150mg daily of a Geranylgeraniol (GG). For weeks 5-8, the dose will be escalated as participants will consume 300mg daily of GG.

Dietary Supplement: GG sourced from Annatto

Interventions

Placebo Supplementation DIETARY_SUPPLEMENT

8 weeks of placebo supplementation

Placebo

GG sourced from Annatto DIETARY_SUPPLEMENT

8-weeks of Geranylgeraniol supplementation

Geranylgeraniol Treatment

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and Females age 30-49 years old
• Males scoring 27-36 on the Aging Males Symptoms scale
• Willing to sign the Informed Consent
• English literate

You may not qualify if:

• Cardiovascular, neurological, metabolic, or endocrine disease
• Drink heavily (\>7 and \>14 drinks per week for women and men, respectively)
• Smoke
• Renal, hematological, or hepatic disorder
• Psychiatric disorder, depression
• Peptic ulcer
• Any malignancy
• Thrombosis
• Undergone surgery that affects digestion and absorption
• Hypo- or hypertensive
• Undergoing hormone replacement therapy
• Using hormone boosting supplements (herbal or synthetic)
• Using drugs that are anti-diabetic, anti-platelet, anti-coagulant, beta blockers, or used to treat ED
• Pregnant or trying to conceive, currently breastfeeding, or have breastfeed within the prior 3 months
• Have participated in a clinical trial within the past 6 months

Sponsors & Collaborators

• Applied Science & Performance Institute: lead

Study Sites (1)

Applied Science and Performance Institute

Tampa, Florida, 33607, United States

Location

Study Design

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

Model Details: Double-blind, parallel, randomized, placebo controlled, dose-escalation trial

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 28, 2022
• Study Start: February 6, 2022
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)