CClinicalTrials.gg
Status unknownNCT01569425M-PCOSUpdated Apr 8, 2015

Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome

An interventional study of Dietary intervention in Hyperandrogenism and Insulin Resistance, sponsored by Tel Aviv University. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-04-08.

Sponsored by Tel Aviv University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Apr 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

In obese women with polycystic ovary syndrome (PCOS), weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms. Weight loss is not required in lean PCOS patients; nevertheless, the influence of meal timing and composition on glucose metabolism and hyperandrogenism may have clinical value. In this study the investigators investigate the effects of two isocaloric diets with different meal timing distribution on insulin resistance and hyperandrogenism in lean PCOS patients.

Read the detailed description

Insulin resistance and hyperinsulinemia plays a pivotal role in the pathogenesis of polycystic ovary syndrome (PCOS). Hyperinsulinemia stimulates ovarian cytochrome P450c17 alpha activity, in obese and nonobese women with PCOS, thereby increasing serum levels of 17-alpha-hydroxyprogesterone, androgens concentrations, decreasing SHBG and promoting the clinical features of hyperandrogenism.

In women with PCOS, weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms. Since lean women with PCOS do not have the option of weight loss, it is important to know weather diet composition and meal timing distribution may influence glucose metabolism and hyperandrogenism.

We hypothesized that a timing pattern of increased nutrient intake of protein and carbohydrates in the morning, with decreased caloric intake at night would improve insulin sensitivity and hyperandrogenism in lean women with PCOS.

Objective:The objective of this study is to investigate the effects of two isocaloric diets with different meal timing distribution on insulin resistance and hyperandrogenism in lean PCOS women.

02

Conditions studied

  • Hyperandrogenism
  • Insulin Resistance

Keywords

  • PCOS
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Tel Aviv University is the lead sponsor of 100 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects ≥18 and ≤45 years of age
  2. Lean women with PCOS (BMI: ≤ 25 kg/m2)
  3. Signed informed consent
  4. Exclusion of late-onset adrenal hyperplasia by a fasting serum 17- hydroxy progesterone concentration below 200 ng/dl.
  5. Acceptable health based on interview, medical history, physical examination, and laboratory tests (SMA20 and CBC).
  6. Not dieting and no change in body weight >10 lb = 4.5 kg within the last 6 months
  7. Stable physical activity pattern during the three months immediately preceding study initiation
  8. Hyperandrogenemia (elevated free testosterone).
  9. Normal liver and kidney function
  10. Fasting blood glucose \<110 mg/dl.
  11. No metabolic disease
  12. Usually wakes up between 05:00 and 07:00 and goes to sleep between 22:00 and 24:00.
  13. Normal TSH and FT4 levels and serum prolactin
  14. Acceptable health based on interview, medical history, physical examination, and laboratory tests

Exclusion criteria

Exclusion Criteria:

  1. Diabetes mellitus diagnosed by fasting glucose or a 2-hour OGTT, or fasting glucose > 110 mg/dl
  2. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease (other than skin cancer).
  3. Current use of oral contraceptives
  4. Serum creatinine level > 1.5 mg/dl
  5. Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
  6. Any physiologic or mechanical problems preventing dietary adherence
  7. Pregnant or lactating
  8. Participating in another dietary program or use of weight-loss medications
  9. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
  10. Use of psychotropic or anoretic medication during the month immediately prior to study onset
  11. Night or rotating shift work
  12. Jet lag during the 2 week period immediately prior to study onset

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05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Lifestyle counseling

    Lifestyle counseling, with high calorie breakfast

    Other: Dietary intervention

  • Active comparator
    Life Counseling

    Diet with high calorie dinner

    Other: Dietary intervention

Interventions

  • OtherDietary intervention

    High Calorie breakfast and high calorie dinner

06

What researchers measure

Primary outcomes

  1. hyperandrogenism

    Androgens will be evaluate at baseline and after one of two isocaloric diet that differe in meal timing distribution

    Time frame: 90 days

Secondary outcomes

  1. glucose metabolism

    Glucose metabolism will be evaluated at baseline and after one of two isocaloric diets that differ in meal timing distribution

    Time frame: 90 days

07

Study locations

1 site
  • Daniela Jakubowicz
    Holon, Tel Aviv 58100, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01569425
Lead sponsor
Tel Aviv University
Responsible party
Daniela Jakubowicz (Prof. Daniela Jakubowicz MD, Tel Aviv University) — Principal investigator
First posted
Apr 3, 2012
Start date
Mar 2012
Primary completion
Jun 2012
Completion
Jun 2015 (estimated)
Last update
Apr 8, 2015

Study contacts

Daniela Jakubowicz, MD
principal investigator · Diabetes Unit E. Wolfson Medical Center Tel Aviv University
Mona Boaz, PhD
study director · E. Wolfson Medical Center Tel Aviv University
Julio Wainstein, MD
study chair · E. Wolfson Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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