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

Sexual Health Clinical Trial

Official title:

The Effects of Oral Supplementation With Geranylgeraniol (GG) Sourced From Annatto on Sexual Health in Males and Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05258513
• Other study ID #: 122102
• Status: Completed
• Phase: N/A
• Start date: February 6, 2022
• Est. completion date: December 9, 2022

Study information

• Verified date: December 2022
• Source: Applied Science & Performance Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Libido
• Sexual Health

Intervention

Dietary Supplement:
• Placebo Supplementation
8 weeks of placebo supplementation
• GG sourced from Annatto
8-weeks of Geranylgeraniol supplementation

Locations

Country	Name	City	State
United States	Applied Science and Performance Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Applied Science & Performance Institute

Country where clinical trial is conducted

United States, 

Outcome

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