Skip to main content
OpenTrials
Completed

NCT Number: NCT01559194

Low Fat Versus Protein Sparing Diet for Weight Loss & Impact on Biomarkers Associated With Breast Cancer Risk

The primary specific aim of this study was to determine if overweight and obese premenopausal women can lose weight and if long term weight loss impacts biomarkers associated with breast cancer risk.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ohio State University

Columbus, Ohio, 43201, United States

About this study

We examined a low carbohydrate diet (40% carbohydrates, 30% protein, 30% fat) versus a low fat diet (60% carbohydrates, 20% protein, 20% fat) to determine the impact of these dietary patterns, combined with exercise, on weight loss, body shape and body composition.

Inclusion criteria

  • Aged 30 and older
  • Premenopausal (may be confirmed by FSH)
  • No previous diagnosis of cancer (except non-melanomatous skin cancer)
  • Body mass index between 25-34 kg/m2
  • Women must be expected to live in the Columbus area for the next 18 months
  • All women must present a letter of medical clearance from their primary care physician

Exclusion criteria

  • Pregnant women or women who plan to become pregnant during the study period will not be enrolled. Women who become pregnant during the intervention will be withdrawn from the study.
  • Women who are already participating in a formal weight loss program (such as Weight Watchers) will not be eligible.
  • Women with a medical history that precludes adherence to either of the two dietary patterns will also be excluded. This includes a history of renal insufficiency, gluten enteropathy, Crohn's disease or other medical conditions that significantly impact nutritional status or metabolism. Women with either type I or controlled type II diabetes will be eligible to participate in this trial.
  • All medical problems must be managed and controlled. Lipid profile, blood glucose, hemoglobin A1c, and blood pressure will be assessed at the screening visit. These results will be reviewed by the study physician. Women who have abnormal values that, at the discretion of the study physician, would benefit from medical management will be referred to a primary care physician prior to considering them for enrollment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 30 and older
  • Premenopausal (may be confirmed by FSH)
  • No previous diagnosis of cancer (except non-melanomatous skin cancer)
  • Body mass index between 25-34 kg/m2
  • Women must be expected to live in the Columbus area for the next 18 months.
  • All women must present a letter of medical clearance from their primary care physician.

Exclusion criteria

  • Pregnant women or women who plan to become pregnant during the study period will not be enrolled. Women who become pregnant during the intervention will be withdrawn from the study.
  • Women who are already participating in a formal weight loss program (such as Weight Watchers)will not be eligible.
  • Women with a medical history that precludes adherence to either of the two dietary patterns will also be excluded. This includes a history of renal insufficiency, gluten enteropathy, Crohn's disease or other medical conditions that significantly impact nutritional status or metabolism. Women with either type I or controlled type II diabetes will be eligible to participate in this trial.
  • All medical problems must be managed and controlled. Lipid profile, blood glucose, hemoglobin A1c, and blood pressure will be assessed at the screening visit. These results will be reviewed by the study physician. Women who have abnormal values that, at the discretion of the study physician, would benefit from medical management will be referred to a primary care physician prior to considering them for enrollment.

Treatment and study plan

Low Fat Diet plus exercise

Behavioral

Low fat diet plus exercise - Subjects were educated about a low fat diet plus exercise and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day.

Low Carbohydrate diet + Exercise

Behavioral

Low carbohydrate diet plus exercise: Subjects were educated about a low carbohydrate diet and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day.

Primary outcomes

  1. Number of women who lose weight when following 1 of 2 different calorie-restricted diets

    Time frame: 18 months

Secondary outcomes

  1. Number of women that long-term weight loss impacted biomarkers (including Insulin-like growth factor (IGF)- 1 and IGFBP-3) associated with breast cancer risk

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • Breast Cancer Research Foundation

Registry information

Official study title

A Randomized Comparison of a Low Fat or Low Carbohydrate Dietary Pattern for Weight Loss and Impact on Biomarkers Associated With Breast Cancer Risk in Overweight and Obese Premenopausal Women: Lifestyle Eating and Fitness

Acronym: LEAF

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Mar 21, 2012
Registry last updated
Apr 14, 2014

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.

Published trials that share one or more normalized conditions with this study.