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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
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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Brief Summary:
The ability of sperm to swim is important for normal fertility. Men with a genetic variation in the gene coding for Choline Dehydrogenase (CHDH) have decreased energy production by sperm, and their sperm do not swim normally. The metabolic product of this gene is a nutrient called betaine (found normally in the diet as a part of many foods such as spinach, beets and grain products). This study tests whether treatment with betaine is safe and whether it can normalize energy production in sperm of these men and restore normal swimming ability.

Condition or disease Intervention/treatment Phase
Men Carrying 2 Minor Alleles for Choline Dehydrogenase rs12676 Male Infertility Drug: Betaine supplement Phase 1

Detailed Description:

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 Design
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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

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Arms and Interventions
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Arm Intervention/treatment
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
Other Name: BetaPower (Dupont Nutrition)


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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 ]
  3. 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

  4. 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

  5. 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

  6. 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 ]

Secondary Outcome Measures :
  1. Betaine intake [ Time Frame: At screening and every 21 days during the study ]
    Assessed using 3-day food records

  2. Change in complete blood count from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]
  3. Change in uric acid concentration from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]
  4. Change in alkaline phosphatase concentration from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]
  5. Change in aspartate transaminase concentration from baseline [ Time Frame: At 0,10, 30, 50, and 75 days on treatment ]
  6. Change in lactic dehydrogenase concentration from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]
  7. Change in bilirubin concentration from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]
  8. Change in blood urea nitrogen concentration from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]
  9. Change in creatinine concentration from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]
  10. Change in urinalysis parameters from baseline [ Time Frame: At 0, 10, 30, 50, and 75 days on treatment ]

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

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, North Carolina
UNC Nutrition Research Institute
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Steven Zeisel, MD, PhD University of North Carolina
More Information
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Publications:

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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
Keywords provided by University of North Carolina, Chapel Hill:
Sperm motility
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Betaine
Gastrointestinal Agents
Lipotropic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents