The Effects of Geranylgeraniol on Blood Safety and Sex Hormone Profiles in Healthy Adults: A Dose-Escalation, Randomized, Placebo-Controlled Trial

Geranylgeraniol (GG), an ingredient extracted from the South American annatto plant, has been shown to benefit bone and muscle health, is crucial in the biosynthesis of menaquinone-4 and coenzyme Q10, and has pain and inflammation reduction activities. However, no known studies to date have demonstr...

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Main Authors: Raad Gheith, Matthew Sharp, Matthew Stefan, Charlie Ottinger, Ryan Lowery, Jacob Wilson
Format: Article
Language:English
Published: MDPI AG 2023-12-01
Series:Nutraceuticals
Subjects:
Online Access:https://www.mdpi.com/1661-3821/3/4/43
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author Raad Gheith
Matthew Sharp
Matthew Stefan
Charlie Ottinger
Ryan Lowery
Jacob Wilson
author_facet Raad Gheith
Matthew Sharp
Matthew Stefan
Charlie Ottinger
Ryan Lowery
Jacob Wilson
author_sort Raad Gheith
collection DOAJ
description Geranylgeraniol (GG), an ingredient extracted from the South American annatto plant, has been shown to benefit bone and muscle health, is crucial in the biosynthesis of menaquinone-4 and coenzyme Q10, and has pain and inflammation reduction activities. However, no known studies to date have demonstrated the safety and impact of GG supplementation in humans. This 8-week, randomized, placebo-controlled, dose-escalated trial was conducted to determine the effect of GG on blood safety and hormone markers in healthy adults. Sixty-six males and females between 30 and 49 years of age were supplemented with either GG or a placebo (PLA) for 8 weeks, with dose escalation from 150 mg to 300 mg occurring after 4 weeks in the treatment group. Changes in complete blood count and comprehensive metabolic panels were analyzed for whole study groups (males and females) while changes in sex hormone panels were analyzed for males and females independently. There were no significant changes in complete blood count, comprehensive metabolic panel, progesterone, estradiol, sex–hormone binding globulin, or dihydrotestosterone (<i>p</i> > 0.05). An exploratory analysis of testosterone levels in a subgroup of males with baseline (Pre) total testosterone < 700 ng/dL (GG = 15; PLA = 13) demonstrated a significant increase (<i>p</i> < 0.05) from Pre to Week 8 in total-, free-, and bioavailable testosterone (+7.5%, +15.0%, and +14.8%, respectively). This study demonstrates that GG does not significantly change the composition of blood chemistry, hematology, or sex hormone profiles in adult males or females. Given the effects observed in the exploratory analysis in a subgroup of males, GG supplementation may be beneficial for testosterone enhancement in male populations subject to low testosterone (i.e., aging males and those with late-onset hypogonadism), but further research is needed.
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spelling doaj.art-ef44e552e4234d1dbf97380919c1883e2023-12-22T14:29:49ZengMDPI AGNutraceuticals1661-38212023-12-013460561810.3390/nutraceuticals3040043The Effects of Geranylgeraniol on Blood Safety and Sex Hormone Profiles in Healthy Adults: A Dose-Escalation, Randomized, Placebo-Controlled TrialRaad Gheith0Matthew Sharp1Matthew Stefan2Charlie Ottinger3Ryan Lowery4Jacob Wilson5Applied Science and Performance Institute, Tampa, FL 33607, USAApplied Science and Performance Institute, Tampa, FL 33607, USAApplied Science and Performance Institute, Tampa, FL 33607, USAApplied Science and Performance Institute, Tampa, FL 33607, USAApplied Science and Performance Institute, Tampa, FL 33607, USAApplied Science and Performance Institute, Tampa, FL 33607, USAGeranylgeraniol (GG), an ingredient extracted from the South American annatto plant, has been shown to benefit bone and muscle health, is crucial in the biosynthesis of menaquinone-4 and coenzyme Q10, and has pain and inflammation reduction activities. However, no known studies to date have demonstrated the safety and impact of GG supplementation in humans. This 8-week, randomized, placebo-controlled, dose-escalated trial was conducted to determine the effect of GG on blood safety and hormone markers in healthy adults. Sixty-six males and females between 30 and 49 years of age were supplemented with either GG or a placebo (PLA) for 8 weeks, with dose escalation from 150 mg to 300 mg occurring after 4 weeks in the treatment group. Changes in complete blood count and comprehensive metabolic panels were analyzed for whole study groups (males and females) while changes in sex hormone panels were analyzed for males and females independently. There were no significant changes in complete blood count, comprehensive metabolic panel, progesterone, estradiol, sex–hormone binding globulin, or dihydrotestosterone (<i>p</i> > 0.05). An exploratory analysis of testosterone levels in a subgroup of males with baseline (Pre) total testosterone < 700 ng/dL (GG = 15; PLA = 13) demonstrated a significant increase (<i>p</i> < 0.05) from Pre to Week 8 in total-, free-, and bioavailable testosterone (+7.5%, +15.0%, and +14.8%, respectively). This study demonstrates that GG does not significantly change the composition of blood chemistry, hematology, or sex hormone profiles in adult males or females. Given the effects observed in the exploratory analysis in a subgroup of males, GG supplementation may be beneficial for testosterone enhancement in male populations subject to low testosterone (i.e., aging males and those with late-onset hypogonadism), but further research is needed.https://www.mdpi.com/1661-3821/3/4/43testosteronehealthherbal extractannattohypogonadal
spellingShingle Raad Gheith
Matthew Sharp
Matthew Stefan
Charlie Ottinger
Ryan Lowery
Jacob Wilson
The Effects of Geranylgeraniol on Blood Safety and Sex Hormone Profiles in Healthy Adults: A Dose-Escalation, Randomized, Placebo-Controlled Trial
Nutraceuticals
testosterone
health
herbal extract
annatto
hypogonadal
title The Effects of Geranylgeraniol on Blood Safety and Sex Hormone Profiles in Healthy Adults: A Dose-Escalation, Randomized, Placebo-Controlled Trial
title_full The Effects of Geranylgeraniol on Blood Safety and Sex Hormone Profiles in Healthy Adults: A Dose-Escalation, Randomized, Placebo-Controlled Trial
title_fullStr The Effects of Geranylgeraniol on Blood Safety and Sex Hormone Profiles in Healthy Adults: A Dose-Escalation, Randomized, Placebo-Controlled Trial
title_full_unstemmed The Effects of Geranylgeraniol on Blood Safety and Sex Hormone Profiles in Healthy Adults: A Dose-Escalation, Randomized, Placebo-Controlled Trial
title_short The Effects of Geranylgeraniol on Blood Safety and Sex Hormone Profiles in Healthy Adults: A Dose-Escalation, Randomized, Placebo-Controlled Trial
title_sort effects of geranylgeraniol on blood safety and sex hormone profiles in healthy adults a dose escalation randomized placebo controlled trial
topic testosterone
health
herbal extract
annatto
hypogonadal
url https://www.mdpi.com/1661-3821/3/4/43
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