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Completed

NCT Number: NCT05258513

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

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.

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Key information

Conditions

Sexual Health Libido

Age range

30 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Science and Performance Institute

Tampa, Florida, 33607, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo supplementation

Dietary Supplement

8 weeks of placebo supplementation

GG sourced from Annatto

Dietary Supplement

8-weeks of Geranylgeraniol supplementation

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. Testosterone

    Time frame: Week 0, 4, and 8

    Experimental outcome examining bioavailable and total testosterone in fasted whole blood samples

  2. Estradiol

    Time frame: Week 0, 4, and 8

    Experimental outcome examining bioavailable and total estradiol in fasted whole blood samples

  3. Progesterone

    Time frame: Week 0, 4, and 8

    Experimental outcome examining bioavailable and total progesterone in fasted whole blood samples

  4. Sex Hormone Binding Globulin (SHBG)

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total SHBG in fasted whole blood samples

  5. Changes in Dihydrotestosterone (DHT)

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total DHT in fasted whole blood samples

  6. Changes in White Blood Cell count

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total White Blood Cell count via fasted whole blood samples

  7. Changes in Red Blood Cell count

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Red Blood Cell count via fasted whole blood samples

  8. Changes in Hemoglobin levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Hemoglobin via fasted whole blood samples

  9. Changes in Hematocrit levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Hematocrit via fasted whole blood samples

  10. Changes in Mean Corpuscular Volume

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Mean Corpuscular Volume via fasted whole blood samples

  11. Changes in Mean Corpuscular Hemoglobin

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Mean Corpuscular Hemoglobin via fasted whole blood samples

  12. Changes in Mean Corpuscular Hemoglobin Concentration

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Mean Corpuscular Hemoglobin Concentration via fasted whole blood samples

  13. Changes in Red Cell Distribution Width

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Red Cell Distribution Width via fasted whole blood samples

  14. Changes in Platelet Count

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Platelet count via fasted whole blood samples

  15. Changes in Mean Platelet Volume

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Mean Platelet volume via fasted whole blood samples

  16. Changes in Granulocyte levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining percentage of Granulocytes via fasted whole blood samples

  17. Changes in Lymphocytes levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining percentage of Lymphocytes via fasted whole blood samples

  18. Changes in Monocyte levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining percentage of Monocytes via fasted whole blood samples

  19. Changes in Eosinophil levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining percentage of Eosinophil via fasted whole blood samples

  20. Changes in Basophil levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining percentage of Basophil via fasted whole blood samples

  21. Changes in Granulocyte count

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Granulocyte via fasted whole blood samples

  22. Changes in Lymphocytes count

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Lymphocytes via fasted whole blood samples

  23. Changes in Monocyte count

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Monocytes via fasted whole blood samples

  24. Changes in Eosinophil count

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Eosinophil via fasted whole blood samples

  25. Changes in Basophil count

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Basophil via fasted whole blood samples

  26. Changes in Glucose levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Glucose via fasted whole blood samples

  27. Changes in Blood Urea Nitrogen levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Blood Urea Nitrogen via fasted whole blood samples

  28. Changes in Serum Creatinine levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Serum Creatinine via fasted whole blood samples

  29. Changes in Sodium levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Sodium via fasted whole blood samples

  30. Changes in Potassium levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Potassium via fasted whole blood samples

  31. Changes in Chloride levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Chloride via fasted whole blood samples

  32. Changes in Carbon Dioxide levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Carbon Dioxide via fasted whole blood samples

  33. Changes in Calcium levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Calcium via fasted whole blood samples

  34. Changes in Total Protein levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Protein via fasted whole blood samples

  35. Changes in Albumin levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Albumin via fasted whole blood samples

  36. Changes in Globulin levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Globulin via fasted whole blood samples

  37. Changes in Total Bilirubin levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Bilirubin via fasted whole blood samples

  38. Changes in Alkaline Phosphatase levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Alkaline Phosphatase via fasted whole blood samples

  39. Changes in Alanine Transaminase levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Alanine Transaminase via fasted whole blood samples

  40. Changes in Aspartate Aminotransferase levels

    Time frame: Week 0, 4, and 8

    Experimental outcome examining total Aspartate Aminotransferase via fasted whole blood samples

  41. Changes in Albumin to Globulin ratio

    Time frame: Week 0, 4, and 8

    Experimental outcome examining the ratio of Albumin to Globulin via fasted whole blood samples

  42. Changes in Blood Urea Nitrogen to Creatinine ratio

    Time frame: Week 0, 4, and 8

    Experimental outcome examining the ratio of Blood Urea Nitrogen to Creatinine via fasted whole blood samples

  43. Changes in estimated Glomerular Filtration Rate

    Time frame: Week 0, 4, and 8

    Experimental outcome examining the Glomerular Filtration rate via fasted whole blood samples

  44. Changes in total mass

    Time frame: Week 0, 4, and 8

    Total mass will be assessed via dual-energy x-ray absorptiometry (DEXA).

  45. Changes in Lean Body Mass

    Time frame: Week 0, 4, and 8

    Total lean body mass will be assessed via dual-energy x-ray absorptiometry (DEXA).

  46. Changes in Fat Mass

    Time frame: Week 0, 4, and 8

    Total fat mass will be assessed via dual-energy x-ray absorptiometry (DEXA).

  47. Changes in Bone Mineral Content

    Time frame: Week 0, 4, and 8

    Bone mineral content will be assessed via dual-energy x-ray absorptiometry (DEXA).

  48. Changes in Bone Mineral Density

    Time frame: Week 0, 4, and 8

    Bone mineral density will be assessed via dual-energy x-ray absorptiometry (DEXA).

  49. Changes in Body Fat Percentage

    Time frame: Week 0, 4, and 8

    Body Fat Percentage will be assessed via dual-energy x-ray absorptiometry (DEXA).

  50. Changes in Body Mass Index

    Time frame: Week 0, 4, and 8

    Body Mass Index will be assessed via dual-energy x-ray absorptiometry (DEXA).

  51. Changes in Grip Strength

    Time frame: Week 0, 4, and 8

    Assessed using a handheld dynamometer

  52. Changes in Energy

    Time frame: Week 0, 4, and 8

    Assessed through a visual analog scale (100mm line), where 0 is no energy at all and 100 is very energized

  53. Changes in Quality of Life

    Time frame: Week 0, 4, and 8

    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.

  54. Changes in Perceived Stress

    Time frame: Week 0, 4, and 8

    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.

  55. Changes in Sleep Quality

    Time frame: Week 0, 4, and 8

    Assessed by administering the Sleep Quality Index (PSQI) for subjective measurement. Values range from 0 to 3 with lower scores demonstrating a better outcome.

  56. Changes in Fatigue

    Time frame: Week 0, 4, and 8

    Assessed by administering the Multidimensional Fatigue Index for subjective measurement. Values range from 1 to 5 with lower scores demonstrating a better outcome.

  57. Changes in Physical Activity

    Time frame: Week 0, 4, and 8

    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.

Other outcomes

  1. Resting Systolic Blood Pressure

    Time frame: Week 0, 4, and 8

    Change in resting systolic blood pressure

  2. Resting Diastolic Blood Pressure

    Time frame: Week 0, 4, and 8

    Change in resting diastolic blood pressure

  3. Adverse Effects

    Time frame: Week 0, 4, and 8

    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.

Sponsors and collaborators

Lead sponsor

Applied Science & Performance Institute

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2022
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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