Sexual HealthNCT05258513
The Effects of Geranylgeraniol (GG) Sourced From Annatto on Sexual Health
A study testing GG sourced from Annatto in people with Sexual Health and Libido, run by Applied Science & Performance Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Health, Libido
- What is being tested?
- GG sourced from Annatto
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2022to 9 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Science and Performance Institute
Tampa, Florida, 33607
About this study
Official title: The Effects of Oral Supplementation With Geranylgeraniol (GG) Sourced From Annatto on Sexual Health in Males and Females
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.
Read the 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)
- Conditions
- Sexual Health, Libido
- Being tested
- Placebo Supplementation, GG sourced from Annatto
- Keywords
- Sexual Health, Libido, Body Composition, Strength, Vitality, Hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo SupplementationDietary supplement
8 weeks of placebo supplementation
GG sourced from AnnattoDietary supplement
8-weeks of Geranylgeraniol supplementation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: GG sourced from Annatto |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 0, 4 and 8
Secondary outcomes (57)
Testosterone
Experimental outcome examining bioavailable and total testosterone in fasted whole blood samples
Measured: Week 0, 4, and 8
Estradiol
Experimental outcome examining bioavailable and total estradiol in fasted whole blood samples
Measured: Week 0, 4, and 8
Progesterone
Experimental outcome examining bioavailable and total progesterone in fasted whole blood samples
Measured: Week 0, 4, and 8
Sex Hormone Binding Globulin (SHBG)
Experimental outcome examining total SHBG in fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Dihydrotestosterone (DHT)
Experimental outcome examining total DHT in fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in White Blood Cell count
Experimental outcome examining total White Blood Cell count via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Red Blood Cell count
Experimental outcome examining total Red Blood Cell count via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Hemoglobin levels
Experimental outcome examining total Hemoglobin via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Hematocrit levels
Experimental outcome examining total Hematocrit via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Mean Corpuscular Volume
Experimental outcome examining total Mean Corpuscular Volume via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Mean Corpuscular Hemoglobin
Experimental outcome examining total Mean Corpuscular Hemoglobin via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Mean Corpuscular Hemoglobin Concentration
Experimental outcome examining total Mean Corpuscular Hemoglobin Concentration via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Red Cell Distribution Width
Experimental outcome examining total Red Cell Distribution Width via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Platelet Count
Experimental outcome examining total Platelet count via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Mean Platelet Volume
Experimental outcome examining total Mean Platelet volume via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Granulocyte levels
Experimental outcome examining percentage of Granulocytes via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Lymphocytes levels
Experimental outcome examining percentage of Lymphocytes via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Monocyte levels
Experimental outcome examining percentage of Monocytes via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Eosinophil levels
Experimental outcome examining percentage of Eosinophil via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Basophil levels
Experimental outcome examining percentage of Basophil via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Granulocyte count
Experimental outcome examining total Granulocyte via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Lymphocytes count
Experimental outcome examining total Lymphocytes via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Monocyte count
Experimental outcome examining total Monocytes via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Eosinophil count
Experimental outcome examining total Eosinophil via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Basophil count
Experimental outcome examining total Basophil via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Glucose levels
Experimental outcome examining total Glucose via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Blood Urea Nitrogen levels
Experimental outcome examining total Blood Urea Nitrogen via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Serum Creatinine levels
Experimental outcome examining total Serum Creatinine via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Sodium levels
Experimental outcome examining total Sodium via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Potassium levels
Experimental outcome examining total Potassium via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Chloride levels
Experimental outcome examining total Chloride via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Carbon Dioxide levels
Experimental outcome examining total Carbon Dioxide via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Calcium levels
Experimental outcome examining total Calcium via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Total Protein levels
Experimental outcome examining total Protein via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Albumin levels
Experimental outcome examining total Albumin via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Globulin levels
Experimental outcome examining total Globulin via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Total Bilirubin levels
Experimental outcome examining total Bilirubin via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Alkaline Phosphatase levels
Experimental outcome examining total Alkaline Phosphatase via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Alanine Transaminase levels
Experimental outcome examining total Alanine Transaminase via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Aspartate Aminotransferase levels
Experimental outcome examining total Aspartate Aminotransferase via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Albumin to Globulin ratio
Experimental outcome examining the ratio of Albumin to Globulin via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in Blood Urea Nitrogen to Creatinine ratio
Experimental outcome examining the ratio of Blood Urea Nitrogen to Creatinine via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in estimated Glomerular Filtration Rate
Experimental outcome examining the Glomerular Filtration rate via fasted whole blood samples
Measured: Week 0, 4, and 8
Changes in total mass
Total mass will be assessed via dual-energy x-ray absorptiometry (DEXA).
Measured: Week 0, 4, and 8
Changes in Lean Body Mass
Total lean body mass will be assessed via dual-energy x-ray absorptiometry (DEXA).
Measured: Week 0, 4, and 8
Changes in Fat Mass
Total fat mass will be assessed via dual-energy x-ray absorptiometry (DEXA).
Measured: Week 0, 4, and 8
Changes in Bone Mineral Content
Bone mineral content will be assessed via dual-energy x-ray absorptiometry (DEXA).
Measured: Week 0, 4, and 8
Changes in Bone Mineral Density
Bone mineral density will be assessed via dual-energy x-ray absorptiometry (DEXA).
Measured: Week 0, 4, and 8
Changes in Body Fat Percentage
Body Fat Percentage will be assessed via dual-energy x-ray absorptiometry (DEXA).
Measured: Week 0, 4, and 8
Changes in Body Mass Index
Body Mass Index will be assessed via dual-energy x-ray absorptiometry (DEXA).
Measured: Week 0, 4, and 8
Changes in Grip Strength
Assessed using a handheld dynamometer
Measured: Week 0, 4, and 8
Changes in Energy
Assessed through a visual analog scale (100mm line), where 0 is no energy at all and 100 is very energized
Measured: Week 0, 4, and 8
Changes in Quality of Life
Assessed by administering the Quality of Life Short Form (SF-36) for subjective measurement. Values range from 1 to 6 with higher scores demonstrating a better outcome.
Measured: Week 0, 4, and 8
Changes in Perceived Stress
Assessed by administering the Perceived Stress Scale (PSS-10) for subjective measurement. Values range from 0 to 4 with lower scores demonstrating a better outcome.
Measured: Week 0, 4, and 8
Changes in Sleep Quality
Assessed by administering the Sleep Quality Index (PSQI) for subjective measurement. Values range from 0 to 3 with lower scores demonstrating a better outcome.
Measured: Week 0, 4, and 8
Changes in Fatigue
Assessed by administering the Multidimensional Fatigue Index for subjective measurement. Values range from 1 to 5 with lower scores demonstrating a better outcome.
Measured: Week 0, 4, and 8
Changes in Physical Activity
Assessed by administering the International Physical Activity Questionnaire (IPAQ) for subjective measurement. Values are calculated by converting participant answers on time and intensity of physical activity to MET minutes with higher scores demonstrating a better outcome.
Measured: Week 0, 4, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start6 Feb 2022
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, parallel, randomized, placebo controlled, dose-escalation trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science & Performance Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258513
- Sponsor's protocol ID
- 122102
- Status last verified
- Dec 2022
- First submitted
- 4 Feb 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral Supplementation With Geranylgeraniol (GG) Sourced From Annatto on Sexual Health in Males and Females
- ClinicalTrials.gov ID
- NCT05258513
- Acronym / sponsor ID
- 122102
- Conditions
- Sexual Health, Libido
- Keywords
- Sexual Health, Libido, Body Composition, Strength, Vitality, Hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, parallel, randomized, placebo controlled, dose-escalation trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo SupplementationFrom 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. |
| Geranylgeraniol Treatment | Experimental | Dietary Supplement: GG sourced from AnnattoFrom 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. |
Who may qualify
- Ages
- 30 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Supplementation8 weeks of placebo supplementation | Dietary supplement | Placebo |
| GG sourced from Annatto8-weeks of Geranylgeraniol supplementation | Dietary supplement | Geranylgeraniol Treatment |
Primary outcome
Changes in Overall Sexual Function
Time frame: Week 0, 4 and 8
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.
Changes in Aging Male Symptoms
Time frame: Week 0, 4, and 8
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.
Changes in Androgen Deficiency in Aging Males Scale
Time frame: Week 0, 4, and 8
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.
Changes in Satisfaction to Treatment
Time frame: Week 4 and 8
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.
Changes in Erection Hardness
Time frame: Week 0, 4 and 8
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.
Changes in Erectile Function
Time frame: Week 0, 4 and 8
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.
Changes in Female Sexual Function
Time frame: Week 0, 4 and 8
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.
Changes in Hot Flashes
Time frame: Week 0, 4 and 8
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.
Changes in Night Sweats
Time frame: Week 0, 4 and 8
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.
57 secondary outcomes
Testosterone
Time frame: Week 0, 4, and 8
Estradiol
Time frame: Week 0, 4, and 8
Progesterone
Time frame: Week 0, 4, and 8
Sex Hormone Binding Globulin (SHBG)
Time frame: Week 0, 4, and 8
Changes in Dihydrotestosterone (DHT)
Time frame: Week 0, 4, and 8
Changes in White Blood Cell count
Time frame: Week 0, 4, and 8
Changes in Red Blood Cell count
Time frame: Week 0, 4, and 8
Changes in Hemoglobin levels
Time frame: Week 0, 4, and 8
Changes in Hematocrit levels
Time frame: Week 0, 4, and 8
Changes in Mean Corpuscular Volume
Time frame: Week 0, 4, and 8
Changes in Mean Corpuscular Hemoglobin
Time frame: Week 0, 4, and 8
Changes in Mean Corpuscular Hemoglobin Concentration
Time frame: Week 0, 4, and 8
Changes in Red Cell Distribution Width
Time frame: Week 0, 4, and 8
Changes in Platelet Count
Time frame: Week 0, 4, and 8
Changes in Mean Platelet Volume
Time frame: Week 0, 4, and 8
Changes in Granulocyte levels
Time frame: Week 0, 4, and 8
Changes in Lymphocytes levels
Time frame: Week 0, 4, and 8
Changes in Monocyte levels
Time frame: Week 0, 4, and 8
Changes in Eosinophil levels
Time frame: Week 0, 4, and 8
Changes in Basophil levels
Time frame: Week 0, 4, and 8
Changes in Granulocyte count
Time frame: Week 0, 4, and 8
Changes in Lymphocytes count
Time frame: Week 0, 4, and 8
Changes in Monocyte count
Time frame: Week 0, 4, and 8
Changes in Eosinophil count
Time frame: Week 0, 4, and 8
Changes in Basophil count
Time frame: Week 0, 4, and 8
Changes in Glucose levels
Time frame: Week 0, 4, and 8
Changes in Blood Urea Nitrogen levels
Time frame: Week 0, 4, and 8
Changes in Serum Creatinine levels
Time frame: Week 0, 4, and 8
Changes in Sodium levels
Time frame: Week 0, 4, and 8
Changes in Potassium levels
Time frame: Week 0, 4, and 8
Changes in Chloride levels
Time frame: Week 0, 4, and 8
Changes in Carbon Dioxide levels
Time frame: Week 0, 4, and 8
Changes in Calcium levels
Time frame: Week 0, 4, and 8
Changes in Total Protein levels
Time frame: Week 0, 4, and 8
Changes in Albumin levels
Time frame: Week 0, 4, and 8
Changes in Globulin levels
Time frame: Week 0, 4, and 8
Changes in Total Bilirubin levels
Time frame: Week 0, 4, and 8
Changes in Alkaline Phosphatase levels
Time frame: Week 0, 4, and 8
Changes in Alanine Transaminase levels
Time frame: Week 0, 4, and 8
Changes in Aspartate Aminotransferase levels
Time frame: Week 0, 4, and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: No
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Comprehensive Sexual Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GG sourced from Annatto in people with Sexual Health and Libido, run by Applied Science & Performance Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Overall Sexual Function (time frame: Week 0, 4 and 8). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.