Choline Dehydrogenase and Sperm Function: Effects of Betaine
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ClinicalTrials.gov Identifier: NCT02122211 |
Recruitment Status :
Completed
First Posted : April 24, 2014
Last Update Posted : September 8, 2016
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Condition or disease | Intervention/treatment | Phase |
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Men Carrying 2 Minor Alleles for Choline Dehydrogenase rs12676 Male Infertility | Drug: Betaine supplement | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Choline Dehydrogenase and Sperm Function: Effects of Betaine |
Study Start Date : | April 2014 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
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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.
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Drug: Betaine supplement
Other Name: BetaPower (Dupont Nutrition) |
- Change in sperm motility from baseline [ Time Frame: On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period ]Assessed using Computer-Aided Sperm Analysis methodology
- Change in sperm count from baseline [ Time Frame: On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period ]
- Change in sperm mitochondrial function from baseline [ Time Frame: On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period ]Using Seahorse biochemical function assessment
- Change in sperm ultrastructure from baseline [ Time Frame: On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period ]Using light and transmission electron microscopy
- Change in sperm choline dehydrogenase concentration from baseline [ Time Frame: On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period ]Assessed by Western Blot analysis
- Change in sperm betaine concentration from baseline [ Time Frame: On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period ]
- Betaine intake [ Time Frame: At screening and every 21 days during the study ]Assessed using 3-day food records
- Change in complete blood count from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]
- Change in uric acid concentration from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]
- Change in alkaline phosphatase concentration from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]
- Change in aspartate transaminase concentration from baseline [ Time Frame: At 0,10, 30, 50, and 75 days on treatment ]
- Change in lactic dehydrogenase concentration from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]
- Change in bilirubin concentration from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]
- Change in blood urea nitrogen concentration from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]
- Change in creatinine concentration from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]
- Change in urinalysis parameters from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02122211
United States, North Carolina | |
UNC Nutrition Research Institute | |
Kannapolis, North Carolina, United States, 28081 |
Principal Investigator: | Steven Zeisel, MD, PhD | University of North Carolina |
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT02122211 |
Other Study ID Numbers: |
13-2424 |
First Posted: | April 24, 2014 Key Record Dates |
Last Update Posted: | September 8, 2016 |
Last Verified: | September 2016 |
Sperm motility |
Infertility Infertility, Male Betaine Gastrointestinal Agents Lipotropic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |