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

NCT05258513 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2022-12-29

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Placebo Supplementation

8 weeks of placebo supplementation

DIETARY_SUPPLEMENT

GG sourced from Annatto

8-weeks of Geranylgeraniol supplementation

Sponsors & Collaborators

  • Applied Science & Performance Institute

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-06
Primary Completion
2022-12-09
Completion
2022-12-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05258513 on ClinicalTrials.gov