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The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913001
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Collaborator:
Nutrisystem, Inc.
Information provided by (Responsible Party):
Kathleen Woolf, New York University

Tracking Information
First Submitted Date  ICMJE September 3, 2016
First Posted Date  ICMJE September 23, 2016
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • blood glucose in mg/dL [ Time Frame: Change from baseline blood glucose concentrations after two weeks. ]
    A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure glucose concentrations
  • Insulin in uIL/mL [ Time Frame: Change from baseline insulin concentrations after two weeks. ]
    A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure insulin concentrations
  • Insulin-like growth factor-1 in ng/mL [ Time Frame: Change from baseline Insulin-like growth factor-1 concentrations after two weeks. ]
    A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure insulin-like growth factor-1 concentrations
  • Insulin-like growth factor binding protein-3 in mg/L [ Time Frame: Change from baseline insulin-like growth factor binding protein-3 concentrations after two weeks. ]
    A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure insulin-like growth factor binding protein-3 concentrations
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
Changes in Acne specific quality of life among participants following a low glycemic load diet or their usual diet for two weeks. [ Time Frame: Change in baseline quality of life after two weeks. ]
Acne specific quality of life will be measured using a validated questionnaire. Acne specific quality of life measured the effect of acne on the participants quality of life.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 21, 2016)
Changes in nutrition self efficacy among participants following a low glycemic load diet or their usual diet for two weeks [ Time Frame: Change in nutrition self-efficacy after two-weeks. ]
Nutrition self-efficacy, or the ability to make diet changes, will be measured using a validated questionnaire.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
Official Title  ICMJE The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
Brief Summary This randomized controlled trial will examine changes in some hormonal markers associated with acne among adults with moderate/severe acne randomized to a low glycemic index and glycemic load diet or usual eating plan for two weeks.
Detailed Description The objectives of this randomized controlled trial are to investigate the impact of a low glycemic index/load eating plan on endocrine aspects of acne. Specifically, this study will examine changes in blood biochemical markers of acne among adults with acne following a modified carbohydrate (low glycemic index/load) eating plan or their usual eating plan for two weeks. An external sponsor, Nutrisystem®, will provide some low glycemic index/load foods to the study participants randomized to the intervention group for two weeks. Study outcomes include changes in glucose, insulin, insulin resistance, insulin-like growth factor-1, and insulin-like growth factor binding protein-3 concentrations.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Other: Low Glycemic Load Diet
    Participants received a diet education on a low glycemic load diet.
  • Other: Usual Eating Plan
    Participants received a diet education to continue with their usual eating plan.
Study Arms  ICMJE
  • Experimental: Low Glycemic Load Diet
    Participants received a diet education to follow a low glycemic load diet and received some low glycemic load staple foods.
    Intervention: Other: Low Glycemic Load Diet
  • Active Comparator: Usual Eating Plan
    Participants received a diet education to continue with their usual diet.
    Intervention: Other: Usual Eating Plan
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2016)
97
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body mass index (BMI) ≥18.5 or <30.0 kg/m2
  • History of moderate or severe facial acne for at least 6 months
  • Able to read and speak the English language

Exclusion Criteria:

  • > 10% weight change within the last 6 months
  • Taking medications known to alter blood glucose or insulin concentrations
  • Medical history of polycystic ovarian syndrome, type 1 diabetes, type 2 diabetes, or pre diabetes
  • Low carbohydrate (<45% of total energy from carbohydrate), glycemic index, or glycemic load diet
  • Female participants that are pregnant or lactating or were pregnant or lactating within the last year
  • Current use of a pacemaker or other battery operated implant
  • Facial hair that would make it difficult for a health care provider to assess facial acne.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02913001
Other Study ID Numbers  ICMJE New York University
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kathleen Woolf, New York University
Study Sponsor  ICMJE New York University
Collaborators  ICMJE Nutrisystem, Inc.
Investigators  ICMJE
Principal Investigator: Kathleen Woolf, PhD New York University
Study Director: Jennifer Burris, PhD New York University
PRS Account New York University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP