Clinical trial NCT05258513: The Effects of Geranylgeraniol (GG) Sourced From Annatto on Sexual Health
Official title: The Effects of Oral Supplementation With Geranylgeraniol (GG) Sourced From Annatto on Sexual Health in Males and Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Health
Libido
Keywords: Sexual Health
Libido
Body Composition
Strength
Vitality
Hormones
Lead sponsor: Applied Science & Performance Institute
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 83
Sex: ALL
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, parallel, randomized, placebo controlled, dose-escalation trial
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes in Overall Sexual Function
timeFrame: Week 0, 4 and 8
measure: Changes in Aging Male Symptoms
timeFrame: Week 0, 4, and 8
measure: Changes in Androgen Deficiency in Aging Males Scale
timeFrame: Week 0, 4, and 8
measure: Changes in Satisfaction to Treatment
timeFrame: Week 4 and 8
measure: Changes in Erection Hardness
timeFrame: Week 0, 4 and 8
measure: Changes in Erectile Function
timeFrame: Week 0, 4 and 8
measure: Changes in Female Sexual Function
timeFrame: Week 0, 4 and 8
measure: Changes in Hot Flashes
timeFrame: Week 0, 4 and 8
measure: Changes in Night Sweats
timeFrame: Week 0, 4 and 8
Secondary outcomes:
measure: Testosterone
timeFrame: Week 0, 4, and 8
measure: Estradiol
timeFrame: Week 0, 4, and 8
measure: Progesterone
timeFrame: Week 0, 4, and 8
measure: Sex Hormone Binding Globulin (SHBG)
timeFrame: Week 0, 4, and 8
measure: Changes in Dihydrotestosterone (DHT)
timeFrame: Week 0, 4, and 8
measure: Changes in White Blood Cell count
timeFrame: Week 0, 4, and 8
measure: Changes in Red Blood Cell count
timeFrame: Week 0, 4, and 8
measure: Changes in Hemoglobin levels
timeFrame: Week 0, 4, and 8
measure: Changes in Hematocrit levels
timeFrame: Week 0, 4, and 8
measure: Changes in Mean Corpuscular Volume
timeFrame: Week 0, 4, and 8
measure: Changes in Mean Corpuscular Hemoglobin
timeFrame: Week 0, 4, and 8
measure: Changes in Mean Corpuscular Hemoglobin Concentration
timeFrame: Week 0, 4, and 8
measure: Changes in Red Cell Distribution Width
timeFrame: Week 0, 4, and 8
measure: Changes in Platelet Count
timeFrame: Week 0, 4, and 8
measure: Changes in Mean Platelet Volume
timeFrame: Week 0, 4, and 8
measure: Changes in Granulocyte levels
timeFrame: Week 0, 4, and 8
measure: Changes in Lymphocytes levels
timeFrame: Week 0, 4, and 8
measure: Changes in Monocyte levels
timeFrame: Week 0, 4, and 8
measure: Changes in Eosinophil levels
timeFrame: Week 0, 4, and 8
measure: Changes in Basophil levels
timeFrame: Week 0, 4, and 8
measure: Changes in Granulocyte count
timeFrame: Week 0, 4, and 8
measure: Changes in Lymphocytes count
timeFrame: Week 0, 4, and 8
measure: Changes in Monocyte count
timeFrame: Week 0, 4, and 8
measure: Changes in Eosinophil count
timeFrame: Week 0, 4, and 8
measure: Changes in Basophil count
timeFrame: Week 0, 4, and 8
measure: Changes in Glucose levels
timeFrame: Week 0, 4, and 8
measure: Changes in Blood Urea Nitrogen levels
timeFrame: Week 0, 4, and 8
measure: Changes in Serum Creatinine levels
timeFrame: Week 0, 4, and 8
measure: Changes in Sodium levels
timeFrame: Week 0, 4, and 8
measure: Changes in Potassium levels
timeFrame: Week 0, 4, and 8
measure: Changes in Chloride levels
timeFrame: Week 0, 4, and 8
measure: Changes in Carbon Dioxide levels
timeFrame: Week 0, 4, and 8
measure: Changes in Calcium levels
timeFrame: Week 0, 4, and 8
measure: Changes in Total Protein levels
timeFrame: Week 0, 4, and 8
measure: Changes in Albumin levels
timeFrame: Week 0, 4, and 8
measure: Changes in Globulin levels
timeFrame: Week 0, 4, and 8
measure: Changes in Total Bilirubin levels
timeFrame: Week 0, 4, and 8
measure: Changes in Alkaline Phosphatase levels
timeFrame: Week 0, 4, and 8
measure: Changes in Alanine Transaminase levels
timeFrame: Week 0, 4, and 8
measure: Changes in Aspartate Aminotransferase levels
timeFrame: Week 0, 4, and 8
measure: Changes in Albumin to Globulin ratio
timeFrame: Week 0, 4, and 8
measure: Changes in Blood Urea Nitrogen to Creatinine ratio
timeFrame: Week 0, 4, and 8
measure: Changes in estimated Glomerular Filtration Rate
timeFrame: Week 0, 4, and 8
measure: Changes in total mass
timeFrame: Week 0, 4, and 8
measure: Changes in Lean Body Mass
timeFrame: Week 0, 4, and 8
measure: Changes in Fat Mass
timeFrame: Week 0, 4, and 8
measure: Changes in Bone Mineral Content
timeFrame: Week 0, 4, and 8
measure: Changes in Bone Mineral Density
timeFrame: Week 0, 4, and 8
measure: Changes in Body Fat Percentage
timeFrame: Week 0, 4, and 8
measure: Changes in Body Mass Index
timeFrame: Week 0, 4, and 8
measure: Changes in Grip Strength
timeFrame: Week 0, 4, and 8
measure: Changes in Energy
timeFrame: Week 0, 4, and 8
measure: Changes in Quality of Life
timeFrame: Week 0, 4, and 8
measure: Changes in Perceived Stress
timeFrame: Week 0, 4, and 8
measure: Changes in Sleep Quality
timeFrame: Week 0, 4, and 8
measure: Changes in Fatigue
timeFrame: Week 0, 4, and 8
measure: Changes in Physical Activity
timeFrame: Week 0, 4, and 8
Other outcomes:
measure: Resting Systolic Blood Pressure
timeFrame: Week 0, 4, and 8
measure: Resting Diastolic Blood Pressure
timeFrame: Week 0, 4, and 8
measure: Adverse Effects
timeFrame: Week 0, 4, and 8
Locations:
city: Tampa
country: United States
facility: Applied Science and Performance Institute
state: Florida
Study officials:
References: