NCT02403804

Brief Summary

The goal is to assess whether, in adult women during the luteal phase of their menstrual cycle, supplementing their diet with either phosphatidylcholine or betaine increases their serum choline levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2015

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

February 3, 2015

Last Update Submit

August 31, 2020

Conditions

Healthy

Keywords

Dietary supplementsserum cholinewomen

Outcome Measures

Primary Outcomes (1)

  • change in serum choline

    4 hours post supplement.- baseline

Secondary Outcomes (6)

  • change in serum choline

    2 hours post supplementation.- baseline

  • change in serum choline

    6 hours post supplementation.- baseline

  • change in serum choline

    8 hours post supplementation.- baseline

  • change in serum choline

    10 hours post supplementation.- baseline

  • change in serum choline

    12 hours post supplementation - baseline

  • +1 more secondary outcomes

Study Arms (1)

All subjects

OTHER

All 3 weeks will occur during luteal phase of menstrual cycle with a two-to-three week washout period between weeks. Week 1: Phosphatidylcholine 3600 mg qam and 2700 mg qpm Week 2: Betaine anhydrous 588 mg qam and 412 mg qpm Week 3: Betaine anhydrous 1000 mg BID

Dietary Supplement: PhosphatidylcholineDietary Supplement: Betaine (588 mg qam and 412 mg qpm)Dietary Supplement: Betaine (1000 mg BID)

Interventions

PhosphatidylcholineDIETARY_SUPPLEMENT

Phosphatidylcholine 3600 mg qam and 2700 mg qpm

All subjects
Betaine (588 mg qam and 412 mg qpm)DIETARY_SUPPLEMENT

Betaine anhydrous 588 mg qam and 412 mg qpm

Also known as: Trimethylglycine
All subjects
Betaine (1000 mg BID)DIETARY_SUPPLEMENT

Betaine anhydrous 1000 mg BID

Also known as: Trimethylglycine
All subjects

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • premenopausal
  • No nicotine use
  • No marijuana use
  • No illicit substance use
  • Weight \>= 90 pounds

You may not qualify if:

  • self-reported body odor of unknown etiology
  • personal or family history of cystathionine beta synthase deficiency (homocystinuria)
  • personal or family history of trimethylaminuria, renal or liver disease, Parkinson's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

PhosphatidylcholinesBetaineBID protein, human

Intervention Hierarchy (Ancestors)

GlycerophospholipidsPhosphatidic AcidsGlycerophosphatesPhospholipidsMembrane LipidsLipidsTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Camille Hoffman, MD

    Denver Health and Hospitals

    PRINCIPAL INVESTIGATOR

  • Randal G Ross, MD

    University of Colorado School of Medicine

    STUDY DIRECTOR

  • Ann Olincy, MD

    University of Colorado School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

March 31, 2015

Study Start

April 1, 2015

Primary Completion

September 29, 2015

Study Completion

September 29, 2015

Last Updated

September 2, 2020

Record last verified: 2020-08

Locations

US(1)