Meal Timing on Glucose and Hyperandrogenism in PCOS Women (MealTimePCOS)

Hospital de Clinicas Caracas

Status: Unknown

Conditions: Polycystic Ovary Syndrome (PCOS) Women

Treatments: Behavioral: Placebo Comparator: Lifestyle counseling Dinner Diet ARM 2; Other: Active Comparator: Lifestyle counseling ARM 1

Study type: Interventional

Funder types: Other

Identifiers

NCT01711476

HCCCBI 018-2008-104

Details and patient eligibility

About

The objective of this study is to investigate the effects of two isocaloric maintenance diets with different meal timing distribution on insulin resistance hyperandrogenism and cytochrome P450c17 alpha activity in lean PCOS women.

The investigators hypothesis is that in lean PCOS women a Breakfast Diet (BD) which consist in high calorie breakfast and reduced dinner, vs Dinner Diet (DD) which consist in high calorie dinner with reduced breakfast; the BD will improve glucose and insulin response to OGTT and would decrease the hyperandrogenism and cytochrome P450c17 alpha activity.

Full description

Hyperinsulinemia plays a central role in the pathogenesis in obese as well as in lean PCOS women. These women are insulin resistant and have compensatory hyperinsulinemia that stimulates ovarian cytochrome P450c17 alpha activity that in turn stimulates ovarian androgen concentrations.

In obese PCOS women, weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms.

Since lean PCOS women do not have the option of weight loss, it is important to know if composition and meal timing distribution may influence glucose metabolism and hyperandrogenism and cytochrome P450c17 alpha activity. 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

Enrollment: 60 estimated patients

Sex: Female

Ages: 22 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

lean women with Polycystic Ovary BMI below 25 kg/m2 Testosterone above 1.0 ng/ml 17 Oh progesterone below 200 ng/ml US of Polycystic Ovaries

Exclusion criteria

Obesity BMI above 25 kg/m2 Diabetes Mellitus Other endocrine disease like hypothyroidism, late onset adrenal hyperplasia Pregnancy Contraceptive or other hormonal treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Lifestyle counseling ARM 1

Active Comparator group

Description:

Arm 1 Breakfast Diet The arm 1 will be assigned to eat High calorie breakfast (800kcal) and reduced dinner (200 kcal) During 90 days from baseline to the end of the trial (day 90)

Treatment:

Other: Active Comparator: Lifestyle counseling ARM 1

Lifestyle counseling ARM 2

Placebo Comparator group

Description:

Lean PCOS women in the Arm 2 will be assigned to do a dinner diet from day 0 to day 90 of the trial

Treatment:

Behavioral: Placebo Comparator: Lifestyle counseling Dinner Diet ARM 2