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NCT Number: NCT02122211

Choline Dehydrogenase and Sperm Function: Effects of Betaine

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.

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Key information

Conditions

Men Carrying 2 Minor Alleles for Choline Dehydrogenase rs12676 Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Infertility Male Urogenital Diseases Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

UNC Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Betaine supplement

Drug

Other names: BetaPower (Dupont Nutrition)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 24, 2014
Registry last updated
Sep 8, 2016

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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