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Targeted Disruption to Cancer Metabolism and Growth Through Dietary Macronutrient Modification

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ClinicalTrials.gov Identifier: NCT03171506
Recruitment Status : Completed
First Posted : May 31, 2017
Last Update Posted : August 10, 2017
Sponsor:
Collaborator:
American Institute for Cancer Research
Information provided by (Responsible Party):
Barbara Gower, University of Alabama at Birmingham

Brief Summary:

The objective of this investigation is to examine the effects of 12 weeks of usual care plus a ketogenic diet (KD) or usual care plus dietary recommendations endorsed by the Academy of Nutrition and Dietetics (AND) in women with ovarian and endometrial cancer. Participants undergo testing at baseline and at 12 weeks; the testing consists of blood draws, questionnaires, and measures of body composition. The baseline visit also includes a meeting with a registered dietitian to discuss the guidelines of the assigned diet.

It is hypothesized that the KD group will have improved cancer outcome measures, beneficial body composition changes, reduced fasting concentrations of glucose and insulin, and higher ratings of patient satisfaction with the diet relative to the AND group.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Endometrial Cancer Other: Ketogenic diet Other: AND diet Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is a randomized clinical trial with a parallel arm design to evaluate the effects of 12 weeks of usual care plus AND or usual care plus KD on women with ovarian and endometrial cancer.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Disruption to Cancer Metabolism Through Dietary Macronutrient Modification
Actual Study Start Date : November 9, 2015
Actual Primary Completion Date : July 18, 2017
Actual Study Completion Date : July 18, 2017


Arm Intervention/treatment
Experimental: Usual care plus ketogenic diet Other: Ketogenic diet
Participants in the usual care plus ketogenic diet group will receive usual care plus dietary counseling in accordance with a ketogenic diet such that ~5% energy comes from carbohydrate, 25% energy from protein, and 70% energy from fat for the duration of the 12 week study.

Placebo Comparator: Usual care plus AND diet Other: AND diet
Participants in the usual care plus AND diet group will receive usual care plus dietary counseling in accordance with the Academy of Nutrition and Dietetics guidelines in 2013 for the duration of the 12 week study.




Primary Outcome Measures :
  1. change in fasting glucose [ Time Frame: 12 weeks ]
    mg/dL

  2. change in fasting insulin [ Time Frame: 12 weeks ]
    uU/mL

  3. change in fasting beta-hydroxybutyrate [ Time Frame: 12 weeks ]
    mM


Secondary Outcome Measures :
  1. CA-125 [ Time Frame: baseline and 12 weeks ]
    U/mL

  2. IGF-1 [ Time Frame: baseline and 12 weeks ]
    ng/mL

  3. IGFBP-1 [ Time Frame: baseline and 12 weeks ]
    ug/mL

  4. markers of inflammation [ Time Frame: baseline and 12 weeks ]
    fasting serum concentrations of a variety of inflammatory markers

  5. total body fat [ Time Frame: baseline and 12 weeks ]
    g, measured by DXA and BIA

  6. regional body fat [ Time Frame: baseline and 12 weeks ]
    g, measured by DXA and BIA

  7. total lean mass [ Time Frame: baseline and 12 weeks ]
    g, measured by DXA and BIA

  8. regional lean mass [ Time Frame: baseline and 12 weeks ]
    g, measured by DXA and BIA

  9. quality of life [ Time Frame: baseline and 12 weeks ]
    Physical and mental health functioning as assessed by the Medical outcomes Study Short Form-12 Health Survey, which produces a physical component summary and mental component summary score.

  10. perceived hunger [ Time Frame: baseline and 12 weeks ]
    Perceived hunger assessed by a visual analog scale

  11. food cravings [ Time Frame: baseline and 12 weeks ]
    Cravings for particular types foods (fats, sweets, starches) as assessed by the Food Craving Inventory

  12. lipids [ Time Frame: baseline and 12 weeks ]
    fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This trial is limited to female participants, as it is a study of ovarian and endometrial cancer patients.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • measurable disease or elevated CA-125
  • classified as normal weight, overweight, or obese (BMI > 18.5)
  • English speaking & reading
  • can sign consent and are willing to be randomized and to adhere to the assigned protocol

Exclusion Criteria:

  • pre-existing medical conditions that preclude enrollment: uncontrolled hypertension, myocardial infarction or cerebrovascular accident in the past six months, unstable angina within the last six months, congestive heart failure, serious infectious diseases, chronic hepatitis, cirrhosis, chronic malabsorption syndrome, chronic pancreatitis, chronic lung disease, major depressive or psychiatric disorder.
  • current or medical condition that affects body weight such as uncontrolled hypo- or hyperthyroidism
  • taking any of the following medications: anti-psychotic agents, monoamine oxidase inhibitors, antibiotics for HIV or tuberculosis, weight loss medications, or have taken weight loss medications in the last six months
  • currently dieting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171506


Sponsors and Collaborators
University of Alabama at Birmingham
American Institute for Cancer Research
Investigators
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Principal Investigator: Barbara A Gower, PhD University of Alabama at Birmingham

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Barbara Gower, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03171506     History of Changes
Other Study ID Numbers: 317972
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Barbara Gower, University of Alabama at Birmingham:
ketogenic diet
carbohydrate-restricted diet

Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Nutrients
Growth Substances
Physiological Effects of Drugs