Diet Composition, Weight Control, and Breast Carcinogenesis

NCT01315483 | Completed

• 1 other identifier: CA125243
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

In the United States, overweight (BMI \> 25 but \< 30 Kg/m2) and obesity (BMI \> 30Kg/m2) are increasing at epidemic rates. A significant association exists between being overweight or obese and breast cancer recurrence and survival. However, evidence continues to accumulate indicating that achieving or maintaining a healthy weight for height (Body Mass Index, BMI, 18.5-25Kg/m2) is associated with a reduced risk for breast cancer and with a decrease in breast cancer associated mortality. Despite this, there is a lack of randomized controlled trials exploring this association and how the process of fat loss or being successful in actually reaching a healthy weight for height differentially affects biomarkers for cancer recurrence. Many dietary approaches for weight loss are currently available to the public, and each purports to offer advantages. However, there is little scientific evidence to indicate how these dietary approaches, some of which vary markedly in the foods that they limit or exclude, affect biomarkers for breast cancer risk. In particular, it is not know whether the critical factor in relation to weight and breast cancer is simply weight loss (negative energy balance), irrespective of the manner in which it is achieved, or if certain dietary approaches affect breast cancer risk biomarkers more favorably than others. Published data from our laboratory suggest that dietary pattern does matter, and therefore the goal of this study is to investigate the effects of two popular weight loss dietary approaches that differ in the extent to which they limit carbohydrate or fat consumption (with effects on dietary glycemic load) compared to a usual care group on prognostic markers for cancer recurrence in postmenopausal breast cancer survivors. The investigators hypothesize that in addition to the anticipated effects of fat loss on circulating levels of bioavailable sex steroid hormones, that the effects of excess fat on breast cancer prognosis can be attributed to three interrelated metabolic processes that affect cancer progression: altered glucose metabolism, chronic inflammation and excessive cellular oxidation.

Conditions

Breast Cancer

Keywords

Breast cancer; survivors; weight lose; dietary pattern

Outcome Measures

Primary Outcomes (1)

• Inflammation Markers

  C-reactive protein, IL-6, TNF-alpha

  Baseline and montlhly for 6 months

Secondary Outcomes (6)

• Body Fat Percentage (%)

  Baseline and monthly for 6 months

• Waist Hip Ratio

  Baseline and monthly for 6 months

• Weight

  Baseline and monthly for 6 months

• Bioavailable sex steroid hormones

  Baseline and monthly for 6 months

• Glucose metabolism

  Baseline and monthly for 6 months

Study Arms (3)

Low fat, high carb weight loss diet

EXPERIMENTAL

Ornish-like weight loss dietary pattern

Other: Weight Loss Dietary Pattern

Low carb, high fat weight loss diet

EXPERIMENTAL

South-Beach-like weight loss diet pattern

Other: Weight Loss Dietary Pattern

Control

NO INTERVENTION

Usual care

Interventions

Weight Loss Dietary Pattern OTHER

Diet-physical activity program creating a weekly negative energy balance equivalent to 3500 kcal. Intervention groups receive PA protocol promoting the Physical Activity Guidelines and translated in step recommendations, but one of two diets with divergent dietary patterns (opposing fat and CHO content) that do not overlap \>+5% in CHO and fat content. Macronutrient values reflect a 'pattern' or ratio within (LC 3:2 ratio for F:CHO; HC 1:4 ratio for F:CHO ) and between diets (LC:HC 3:1 for fat; LC:HC 1:2 for CHO). Six-week meal plans for five calorie levels available and incorporate educational material, supporting program components (e.g. self monitoring tools) and core competencies reinforcing weight loss behaviors in order to promote high levels of dietary adherence.

Also known as: Low fat, high carb weight loss diet (Vivace Diet), Low carb, high fat weight loss diet (Ricca Diet)

Low carb, high fat weight loss diet; Low fat, high carb weight loss diet

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female breast cancer survivors
• Staged, resected breast cancer (\> 4-months post radiation treatment, chemotherapy or surgery)
• Post-menopausal (no menses for \> 6 months)
• No evidence of metastatic breast disease
• Willing to follow the diet plan prescribed
• Willing to follow the guidelines for alcohol consumption (no more than 1 standard alcoholic drink per day where one serving is defined as 12oz beer, 5 oz wine OR 1 oz hard liquor)
• Willing to maintain or increase current physical activity level
• Willing to wear a pedometer and keep a daily record of steps
• Willing to wear heart rate/ accelerometer device (Actiheart) continuously (24/7) for one week at the start and end of the study
• Willing to wear a body or swim suit and cap for body composition tests
• Willing to record food intake daily
• Willing to come to RMCC Rose for 11 individual and 5 group sessions over a 6 month period
• Willing to provide urine and fasting blood samples at 7 visits during the study
• Willing to make the commitment it takes to lose weight for the study
• Must have a Body Mass Index between 25Kg/m2 to 35Kg/m2.

You may not qualify if:

• Anticipates having surgery during the next 6 months
• Follows a special diet, e.g. gluten free, casein free, dairy free, vegetarian or other
• Lost 4 or more pounds during the previous month
• Taking weight loss medications during the study
• Being treated by a physician for diabetes
• Has an eating disorder
• Has digestive problems such as IBS (Irritable Bowel Syndrome), Crohn's or other
• Has had surgery involving constriction or removal of any portion of the gastrointestinal tract (gastric bypass, lap-band, bowel resection, colostomy etc.
• Diagnosed with hepatitis B, hepatitis C or HIV
• Has electronic devices implanted in their body (pacemaker, vagus nerve stimulator)
• Must not use any tobacco products

Sponsors & Collaborators

• Colorado State University: lead

Study Sites (1)

Rocky Mountain Cancer Center

Denver, Colorado, 80220, United States

Location

Related Publications (1)

• Thompson HJ, Sedlacek SM, Playdon MC, Wolfe P, McGinley JN, Paul D, Lakoski SG. Weight loss interventions for breast cancer survivors: impact of dietary pattern. PLoS One. 2015 May 26;10(5):e0127366. doi: 10.1371/journal.pone.0127366. eCollection 2015.

  PMID: 26010254 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Henry J Thompson, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

• Scot M Sedlacek, MD

  Rocky Mountain Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 15, 2011
• Study Start: September 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

US (1)