Choline Dehydrogenase and Sperm Function: Effects of Betaine
Palavras-chave
Resumo
Descrição
Unidentified genetic aberrations such as single nucleotide polymorphisms (SNPs) may be the underlying cause of many cases of idiopathic infertility in men. Choline dehydrogenase (encoded by CHDH) converts choline to betaine in the mitochondria. 5-9% of men have 2 alleles for a functional SNP in CHDH (rs12676), and they have low sperm adenosine triphosphate (ATP) concentrations with impaired sperm motility (asthenospermia) that should decrease fertility. Male mice in which CHDH is deleted also have very low sperm ATP, asthenospermia and are infertile. Supplementation of these mice with dietary betaine increases sperm motility and ATP concentrations.
This purpose of this study is to conduct a phase I study of betaine treatment in men with 2 minor alleles for CHDH rs12676 to determine whether betaine supplementation is safe and to obtain preliminary data on the effects of betaine on sperm mitochondrial ATP concentrations and sperm motility in these men.
datas
| Última verificação: | 08/31/2016 |
| Enviado pela primeira vez: | 04/16/2014 |
| Inscrição estimada enviada: | 04/21/2014 |
| Postado pela primeira vez: | 04/23/2014 |
| Última atualização enviada: | 09/06/2016 |
| Última atualização postada: | 09/07/2016 |
| Data real de início do estudo: | 03/31/2014 |
| Data Estimada de Conclusão Primária: | 06/30/2016 |
| Data Estimada de Conclusão do Estudo: | 06/30/2016 |
Condição ou doença
Intervenção / tratamento
Drug: Betaine supplement
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Experimental: Betaine supplement Will use powdered betaine (BetaPower, Dupont Nutrition) that is commercially available for food uses. This powder will be delivered as capsules containing 0.5 gram of powdered betaine which will be administered as eleven capsules twice per day (6 in the morning, 5 in the evening) for a daily total of 6 grams of betaine. | Drug: Betaine supplement |
Critério de eleição
| Idades qualificadas para estudar | 18 Years Para 18 Years |
| Sexos elegíveis para estudo | Male |
| Aceita Voluntários Saudáveis | sim |
| Critério | Inclusion Criteria: - 18 - 60 year old men of multiple races and ethnicities - Estimated dietary intake of betaine of <150 mg/day - Carrying two alleles of the rs 12676 single nucleotide polymorphism Exclusion Criteria: - Cystathionine-beta-synthase (CBS) deficiency - Currently taking betaine supplements - Currently receiving chemotherapy, radiation or any gonadotoxic drug - Female gender |
Resultado
Medidas de Resultado Primário
1. Change in sperm motility from baseline [On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period]
2. Change in sperm count from baseline [On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period]
3. Change in sperm mitochondrial function from baseline [On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period]
4. Change in sperm ultrastructure from baseline [On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period]
5. Change in sperm choline dehydrogenase concentration from baseline [On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period]
6. Change in sperm betaine concentration from baseline [On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period]
Medidas de Resultado Secundário
1. Betaine intake [At screening and every 21 days during the study]
2. Change in complete blood count from baseline [At 0, 10, 30, 50, and 75 days on treatment]
3. Change in uric acid concentration from baseline [At 0, 10, 30, 50, and 75 days on treatment]
4. Change in alkaline phosphatase concentration from baseline [At 0, 10, 30, 50, and 75 days on treatment]
5. Change in aspartate transaminase concentration from baseline [At 0,10, 30, 50, and 75 days on treatment]
6. Change in lactic dehydrogenase concentration from baseline [At 0, 10, 30, 50, and 75 days on treatment]
7. Change in bilirubin concentration from baseline [At 0, 10, 30, 50, and 75 days on treatment]
8. Change in blood urea nitrogen concentration from baseline [At 0, 10, 30, 50, and 75 days on treatment]
9. Change in creatinine concentration from baseline [At 0, 10, 30, 50, and 75 days on treatment]
10. Change in urinalysis parameters from baseline [At 0, 10, 30, 50, and 75 days on treatment]
