Evaluation of Ovarian Morphology and Function in Overweight Women During Weight Loss

NCT01785719 | Completed Results

• 3 other identifiers: OSP 69298R56HD089962R01HD093748-01
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to explore the effects of weight loss on body composition, metabolic status, reproductive hormones, and ovarian follicle development in obese women with regular menstrual cycles versus obese women with irregular menstrual cycles and/or polycystic ovary syndrome (PCOS).

Conditions

Weight Loss; Anovulation; Amenorrhea; Infertility

Keywords

Weight Loss; Polycystic Ovary Syndrome (PCOS); Ovarian Follicle Development; Metabolism

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Ovulatory/Menstrual Function

  Participants with irregular menstrual cycles at baseline were categorized as "responders" or "non-responders" based on any changes they experienced in menstrual cyclicity over the course of the intervention. "Responders" were defined as participants who shifted towards a more favorable menstrual cycle status over the course of the intervention. "Non-responders" were defined as participants who experienced no change or a shift to a less favorable menstrual cycle status over the course of the intervention. Menstrual cycle status categories were defined as "Amenorrhea" (mean cycle length\>90 days; least favorable), "Oligomenorrhea" (mean cycle length 36-90 days; unfavorable), and "Regular" (mean cycle length 21-35 days; most favorable). All participants with regular menstrual cycles at baseline maintained regular cycles over the course of the intervention and were therefore not included in this analysis.

  Up to 7 months

Secondary Outcomes (7)

• Change From Baseline Follicle Number Per Ovary

  Up to 7 months

• Change From Baseline Reproductive Hormones

  Up to 7 months

• Change From Baseline Metabolic Status (HOMA-IR)

  Up to 7 months

• Change From Baseline Total Percent Body Fat

  Up to 7 months

• Change From Baseline Ovarian Volume

  Up to 7 months

Study Arms (1)

Overweight Women

EXPERIMENTAL

Regardless of reproductive history, each participant will be provided with six months of the commercial weight loss program, Nutrisystem® D. Nutrisystem® D is a portion-controlled, low calorie, and low glycemic index meal delivery system that provides 1250-1500 kcal/day. It has been proven to help overweight adults achieve real and sustainable weight loss results. When meals and snacks are consumed as instructed, average weight loss is 1-2 lbs per week or 15-20% body weight by the end of six months. Nutrisystem® D offers a balanced meal plan that is consistent with the nutrition recommendations of the USDA for Americans and American Diabetes Association. Each participant will be encouraged to take a daily multivitamin to help meet her micronutrient needs on the program.

Behavioral: Commercial Weight Loss Program

Interventions

Commercial Weight Loss Program BEHAVIORAL

Regardless of reproductive history, each participant will be provided with six months of the commercial weight loss program, Nutrisystem® D. Nutrisystem® D is a portion-controlled, low calorie, and low glycemic index meal delivery system that provides 1250-1500 kcal/day. It has been proven to help overweight adults achieve real and sustainable weight loss results. When meals and snacks are consumed as instructed, average weight loss is 1-2 lbs per week or 15-20% body weight by the end of six months. Nutrisystem® D offers a balanced meal plan that is consistent with the nutrition recommendations of the USDA Dietary Guidelines for Americans and American Diabetes Association. Each participant will be encouraged to take a daily multivitamin to help meet her micronutrient needs on the program.

Overweight Women

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI ≥ 30.0 kg/m\*m.
• Self-reported history of regular menstrual cycles, irregular menstrual cycles, or PCOS.
• Absence of hormonal contraception, fertility therapy, or insulin-sensitizing medication in the three months prior to enrollment.

You may not qualify if:

• Pregnant, breastfeeding, or lactating
• Lack of one or both ovaries and/or uterus
• Previous diagnosis of bleeding disorder(s) or current use of blood thinners/anticoagulants
• Vegan or gluten free
• Soy or peanut allergy

Sponsors & Collaborators

• Cornell University: lead
• Nutrisystem, Inc.: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Cornell University - Human Metabolic Research Unit

Ithaca, New York, 14853, United States

Location

Related Publications (3)

• Carter FE, Jarrett BY, Lee ND, Zaman N, Reich AM, Wilson KA, Oldfield AL, Vanden Brink H, Lujan ME. Changes in antral follicle dynamics following weight loss in women with polycystic ovary syndrome. Hum Reprod. 2025 Nov 1;40(11):2161-2171. doi: 10.1093/humrep/deaf169.

  PMID: 40929646 DERIVED

• Oldfield AL, Carter FE, Reeves RE, Jarrett BY, Vanden Brink H, Lujan ME. Impact of a hypocaloric dietary intervention on antral follicle dynamics in eumenorrheic women with obesity. Hum Reprod. 2024 Apr 3;39(4):801-811. doi: 10.1093/humrep/deae017.

  PMID: 38335228 DERIVED

• Oldfield AL, Vanden Brink H, Carter FE, Jarrett BY, Lujan ME. Obesity is associated with alterations in antral follicle dynamics in eumenorrheic women. Hum Reprod. 2023 Mar 1;38(3):459-470. doi: 10.1093/humrep/dead007.

  PMID: 36708012 DERIVED

MeSH Terms

Conditions

Weight Loss; Anovulation; Amenorrhea; Infertility; Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Menstruation Disturbances; Pathologic Processes; Ovarian Cysts; Cysts; Neoplasms

Results Point of Contact

• Title: Marla Lujan, PhD
• Organization: Cornell University

mel245@cornell.edu

(607) 255-3153

Study Officials

• Marla Lujan, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: The researchers plan to recruit two cohorts of obese women to the study: (1) those with irregular menstrual cycles and/or PCOS and (2) those with regular menstrual cycles. Both of the cohorts will receive the same intervention.

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 7, 2013
• Study Start: January 1, 2013
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Locations

US (1)