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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Health; Libido
• Intervention / Treatment: Dietary supplement: Placebo Supplementation; Dietary supplement: GG sourced from Annatto

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 Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33607
      • Applied Science and Performance Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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; 8 weeks of placebo supplementation
Experimental: Geranylgeraniol Treatment; 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; 8-weeks of Geranylgeraniol supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testosterone	Experimental outcome examining bioavailable and total testosterone in fasted whole blood samples	Week 0, 4, and 8
Estradiol	Experimental outcome examining bioavailable and total estradiol in fasted whole blood samples	Week 0, 4, and 8
Progesterone	Experimental outcome examining bioavailable and total progesterone in fasted whole blood samples	Week 0, 4, and 8
Sex Hormone Binding Globulin (SHBG)	Experimental outcome examining total SHBG in fasted whole blood samples	Week 0, 4, and 8
Changes in Dihydrotestosterone (DHT)	Experimental outcome examining total DHT in fasted whole blood samples	Week 0, 4, and 8
Changes in White Blood Cell count	Experimental outcome examining total White Blood Cell count via fasted whole blood samples	Week 0, 4, and 8
Changes in Red Blood Cell count	Experimental outcome examining total Red Blood Cell count via fasted whole blood samples	Week 0, 4, and 8
Changes in Hemoglobin levels	Experimental outcome examining total Hemoglobin via fasted whole blood samples	Week 0, 4, and 8
Changes in Hematocrit levels	Experimental outcome examining total Hematocrit via fasted whole blood samples	Week 0, 4, and 8
Changes in Mean Corpuscular Volume	Experimental outcome examining total Mean Corpuscular Volume via fasted whole blood samples	Week 0, 4, and 8
Changes in Mean Corpuscular Hemoglobin	Experimental outcome examining total Mean Corpuscular Hemoglobin via fasted whole blood samples	Week 0, 4, and 8
Changes in Mean Corpuscular Hemoglobin Concentration	Experimental outcome examining total Mean Corpuscular Hemoglobin Concentration via fasted whole blood samples	Week 0, 4, and 8
Changes in Red Cell Distribution Width	Experimental outcome examining total Red Cell Distribution Width via fasted whole blood samples	Week 0, 4, and 8
Changes in Platelet Count	Experimental outcome examining total Platelet count via fasted whole blood samples	Week 0, 4, and 8
Changes in Mean Platelet Volume	Experimental outcome examining total Mean Platelet volume via fasted whole blood samples	Week 0, 4, and 8
Changes in Granulocyte levels	Experimental outcome examining percentage of Granulocytes via fasted whole blood samples	Week 0, 4, and 8
Changes in Lymphocytes levels	Experimental outcome examining percentage of Lymphocytes via fasted whole blood samples	Week 0, 4, and 8
Changes in Monocyte levels	Experimental outcome examining percentage of Monocytes via fasted whole blood samples	Week 0, 4, and 8
Changes in Eosinophil levels	Experimental outcome examining percentage of Eosinophil via fasted whole blood samples	Week 0, 4, and 8
Changes in Basophil levels	Experimental outcome examining percentage of Basophil via fasted whole blood samples	Week 0, 4, and 8
Changes in Granulocyte count	Experimental outcome examining total Granulocyte via fasted whole blood samples	Week 0, 4, and 8
Changes in Lymphocytes count	Experimental outcome examining total Lymphocytes via fasted whole blood samples	Week 0, 4, and 8
Changes in Monocyte count	Experimental outcome examining total Monocytes via fasted whole blood samples	Week 0, 4, and 8
Changes in Eosinophil count	Experimental outcome examining total Eosinophil via fasted whole blood samples	Week 0, 4, and 8
Changes in Basophil count	Experimental outcome examining total Basophil via fasted whole blood samples	Week 0, 4, and 8
Changes in Glucose levels	Experimental outcome examining total Glucose via fasted whole blood samples	Week 0, 4, and 8
Changes in Blood Urea Nitrogen levels	Experimental outcome examining total Blood Urea Nitrogen via fasted whole blood samples	Week 0, 4, and 8
Changes in Serum Creatinine levels	Experimental outcome examining total Serum Creatinine via fasted whole blood samples	Week 0, 4, and 8
Changes in Sodium levels	Experimental outcome examining total Sodium via fasted whole blood samples	Week 0, 4, and 8
Changes in Potassium levels	Experimental outcome examining total Potassium via fasted whole blood samples	Week 0, 4, and 8
Changes in Chloride levels	Experimental outcome examining total Chloride via fasted whole blood samples	Week 0, 4, and 8
Changes in Carbon Dioxide levels	Experimental outcome examining total Carbon Dioxide via fasted whole blood samples	Week 0, 4, and 8
Changes in Calcium levels	Experimental outcome examining total Calcium via fasted whole blood samples	Week 0, 4, and 8
Changes in Total Protein levels	Experimental outcome examining total Protein via fasted whole blood samples	Week 0, 4, and 8
Changes in Albumin levels	Experimental outcome examining total Albumin via fasted whole blood samples	Week 0, 4, and 8
Changes in Globulin levels	Experimental outcome examining total Globulin via fasted whole blood samples	Week 0, 4, and 8
Changes in Total Bilirubin levels	Experimental outcome examining total Bilirubin via fasted whole blood samples	Week 0, 4, and 8
Changes in Alkaline Phosphatase levels	Experimental outcome examining total Alkaline Phosphatase via fasted whole blood samples	Week 0, 4, and 8
Changes in Alanine Transaminase levels	Experimental outcome examining total Alanine Transaminase via fasted whole blood samples	Week 0, 4, and 8
Changes in Aspartate Aminotransferase levels	Experimental outcome examining total Aspartate Aminotransferase via fasted whole blood samples	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	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	Week 0, 4, and 8
Changes in estimated Glomerular Filtration Rate	Experimental outcome examining the Glomerular Filtration rate via fasted whole blood samples	Week 0, 4, and 8
Changes in total mass	Total mass will be assessed via dual-energy x-ray absorptiometry (DEXA).	Week 0, 4, and 8
Changes in Lean Body Mass	Total lean body mass will be assessed via dual-energy x-ray absorptiometry (DEXA).	Week 0, 4, and 8
Changes in Fat Mass	Total fat mass will be assessed via dual-energy x-ray absorptiometry (DEXA).	Week 0, 4, and 8
Changes in Bone Mineral Content	Bone mineral content will be assessed via dual-energy x-ray absorptiometry (DEXA).	Week 0, 4, and 8
Changes in Bone Mineral Density	Bone mineral density will be assessed via dual-energy x-ray absorptiometry (DEXA).	Week 0, 4, and 8
Changes in Body Fat Percentage	Body Fat Percentage will be assessed via dual-energy x-ray absorptiometry (DEXA).	Week 0, 4, and 8
Changes in Body Mass Index	Body Mass Index will be assessed via dual-energy x-ray absorptiometry (DEXA).	Week 0, 4, and 8
Changes in Grip Strength	Assessed using a handheld dynamometer	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	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.	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.	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.	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.	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.	Week 0, 4, and 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting Systolic Blood Pressure	Change in resting systolic blood pressure	Week 0, 4, and 8
Resting Diastolic Blood Pressure	Change in resting diastolic blood pressure	Week 0, 4, and 8
Adverse Effects	Defined as participants self-reported adverse effects. Items that will be surveyed are headache, dizziness, nausea, vomiting, indigestion, blurred vision, lethargy, swelling, itching, chest pain, heart palpitations, difficulty breathing, lethargy, and muscle cramps.	Week 0, 4, and 8

Collaborators and Investigators

• Sponsor: Applied Science & Performance Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2022
• Primary Completion (Actual): December 9, 2022
• Study Completion (Actual): December 9, 2022

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Body Composition; Strength; Sexual Health; Hormones; Vitality; Libido
• Other Study ID Numbers: 122102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No