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OpenTrials
Completed

NCT Number: NCT00579540

Compare Effects of Flax Seed Oil, and Fish Oil on Blood Sugar Levels

Flax seed oil, fish oil, and soy bean oil, are commonly recommended supplements for Polycystic Ovarian Syndrome (PCOS). These oils have different chemical structures and biological actions. It is not yet known which of these oils has the most beneficial effects in PCOS patients because they have never been compared to each other head to head. In this study the researchers hope to learn more about the effects of these oils on blood sugar and insulin levels.

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Key information

Conditions

Polycystic Ovarian Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis

Sacramento, California, 95817, United States

About this study

The aim is to investigate whether n-3 PUFA's can be used to prevent postprandial hypoglycemia and its unfavorable consequences, such as stimulation of cortisol and adrenal androgen secretion, in women with polycystic ovarian syndrome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Females ages 18-45
  • Women who are overweight, and have irregular periods or have been diagnosed with Polycystic Ovarian Syndrome

Exclusion criteria

  • Use of oral contraceptives
  • Impaired glucose tolerance
  • Diabetes mellitus, and any other systemic illnesses such as renal, hepatic, gastrointestinal, severe hyperlipidemia and hypertension that require medication
  • Schizophrenia
  • Having a pacemaker
  • Current viral infection
  • Smoking alcohol intake (more than 2 drinks/week)

Treatment and study plan

Flax Seed Oil

Dietary Supplement

Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.

Fish Oil

Dietary Supplement

Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.

Soybean Oil

Dietary Supplement

Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.

Primary outcomes

  1. We hope to learn more about the effects of fish oil, flax seed oil, and soybean oil, on blood sugar and insulin levels in PCOS patients

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Official study title

CCRC: Prevention of Post-Prandial Hypoglycemia Using n-3/n-6 PUFA in PCOS

Acronym: PCOS

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 24, 2007
Registry last updated
May 30, 2017

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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