Healthy Eating for Reproductive Health: Greenville

NCT01716429 | Withdrawn

• 1 other identifier: Pro00019109
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a 6-month intervention that is examining how different dietary approached may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy, particularly by measuring changes in weight. Participants will be randomly assigned to following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic index, which means the consumer will be asked to favor foods that don't cause a quick rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will receive counseling and supporting materials on the dietary approach the participants are assigned to follow. Both diets are safe and have shown to be effective ways to assist with achieving a healthy weight. The investigators hypothesize that both groups will see improvements in weight and fertility with possible greater improvements seen among participants in the vegan group.

Conditions

Polycystic Ovarian Syndrome; Infertility; Obesity; Overweight

Keywords

vegetarian; vegan; low calorie; weight Loss; infertility; PCOS

Outcome Measures

Primary Outcomes (1)

• Changes in body weight

  6 months

Secondary Outcomes (1)

• Pregnancy rates

  6 months

Other Outcomes (1)

• Menstrual cycle length

  6 months

Study Arms (2)

Low Calorie

ACTIVE COMPARATOR

Participants in this arm will be instructed on how to reduce their caloric intake and follow a low calorie diet

Behavioral: Low calorie diet

Vegan diet

EXPERIMENTAL

Participants in this arm will follow a very low fat diet (\~10% kcals from fat) and also a diet that has a low glycemic index and is free of animal products (vegan)

Behavioral: Vegan diet

Interventions

Vegan diet BEHAVIORAL

Vegan dietary approaches for weight loss

Also known as: Vegetarian

Vegan diet

Low calorie diet BEHAVIORAL

Reduced calorie diet for weight loss

Also known as: Standard diet

Low Calorie

Eligibility Criteria

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

You may qualify if:

• Women must meet the following criteria:
• have been attempting pregnancy for at least 6 months is not currently pregnant has a clinical diagnosis of PCOS is not on oral medications for insulin resistance (such as metformin) or, if currently on such a medication, has been on the medication at a stable dose for at least 3 months willing not use fertility-enhancing medications over the 6-month study (with the exception of oral medications, such as clomiphene citrate, as directed by their physician) willing to be randomized to either dietary condition and able to make weekly meetings.

You may not qualify if:

• Participants should not be in this study if they meet any of the following criteria:
• have not been diagnoses with polycystic ovarian syndrome have been trying to conceive less than 6 months have a Body Mass Index less than 25 or greater than 45 kg/m2 are currently pregnant are younger than 18 or older than 35 years of age are a smoker are unable to come to the Columbia, SC area at least 3-4 times in a 6 month time period for assessments don't have access to the Internet and a computer don't have access to a scale for self-monitoring weight aren't willing to be randomized to either group have a psychiatric disease, drug or alcohol dependency, or uncontrolled thyroid condition have a major health condition, such as heart conditions, diabetes, and past incidence of stroke unable to receive consent from your doctor to participate if you currently are on blood pressure medications, have issues with dizziness, or have bone or joint issues have an eating disorder currently participating in a weight loss program or taking weight loss medications

Sponsors & Collaborators

• University of South Carolina: lead
• Prisma Health-Upstate: collaborator

Study Sites (1)

Fertility Center of the Carolinas: Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility; Obesity; Overweight; Weight Loss

Interventions

Diet, Vegan; Diet, Vegetarian; Caloric Restriction

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; 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; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Energy Intake

Study Officials

• Brie Turner-McGrievy, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 18, 2019

Record last verified: 2013-09

Locations

US (1)