The Effects of Geranylgeraniol (GG) Sourced From Annatto on Sexual Health
Condition: Sexual Health; Libido
Study type: Interventional

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.
    

Detailed description: 
      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.

      Participants will be assessed for the following variables on Week 0, 4, and 8:

      Primary Variables:

      Subjective measures related to sexual health by administering the following questionnaire in
      both Males and Females

        -  Derogatis interview for sexual functioning self report (DISF-SR)

      Subjective measures to Male specific questionnaires:

        -  Aging Male Symptoms (AMS)

        -  Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS)

        -  Erection Hardness Satisfaction (EHS)

        -  Index of Erectile Function (IIEF-5)

        -  Androgen Deficiency in Aging Male (ADAM) in those >40 years old

      Subjective measures to Females specific questionnaires:

        -  Hot flashes and night sweats

        -  Female Sexual Function Index

      Secondary variables:

        -  Bone density, lean mass, and body fat percentage via Dual Energy X-Ray Absorptiometry
           (DEXA)

        -  Hand grip strength assessed via handheld dynamometer

        -  Bioavailable and total testosterone, estradiol, progesterone, Dihydrotestosterone (DHT),
           and Sex Hormone Binding Globulin (SHBG) in blood serum

      Subjective measures related to well-being via the following questionnaires:

        -  Quality of life (SF-36)

        -  Perceived stress scale 10 (PSS-10)

        -  Sleep quality index

        -  Multidimensional fatigue index

        -  International physical activity questionnaire (IPAQ)
    

Intervention name(s): Placebo Supplementation; GG sourced from Annatto
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 8 weeks of placebo supplementation; 8-weeks of Geranylgeraniol supplementation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, parallel, randomized, placebo controlled, dose-escalation trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sexual Health; Libido; Body Composition; Strength; Vitality; Hormones