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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low Glycemic Load Diet
Usual Eating Plan
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Diet, glycemic index, glycemic load, Acne Vulgaris

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Low Glycemic Load Diet

    Usual Eating Plan

    Arm Description

    Participants received a diet education to follow a low glycemic load diet and received some low glycemic load staple foods.

    Participants received a diet education to continue with their usual diet.

    Outcomes

    Primary Outcome Measures

    blood glucose in mg/dL
    A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure glucose concentrations
    Insulin in uIL/mL
    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
    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
    A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure insulin-like growth factor binding protein-3 concentrations

    Secondary Outcome Measures

    Changes in Acne specific quality of life among participants following a low glycemic load diet or their usual diet for 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.

    Full Information

    First Posted
    September 3, 2016
    Last Updated
    October 31, 2022
    Sponsor
    New York University
    Collaborators
    Nutrisystem, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02913001
    Brief Title
    The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
    Official Title
    The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    New York University
    Collaborators
    Nutrisystem, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acne Vulgaris
    Keywords
    Diet, glycemic index, glycemic load, Acne Vulgaris

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    97 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low Glycemic Load Diet
    Arm Type
    Experimental
    Arm Description
    Participants received a diet education to follow a low glycemic load diet and received some low glycemic load staple foods.
    Arm Title
    Usual Eating Plan
    Arm Type
    Active Comparator
    Arm Description
    Participants received a diet education to continue with their usual diet.
    Intervention Type
    Other
    Intervention Name(s)
    Low Glycemic Load Diet
    Intervention Description
    Participants received a diet education on a low glycemic load diet.
    Intervention Type
    Other
    Intervention Name(s)
    Usual Eating Plan
    Intervention Description
    Participants received a diet education to continue with their usual eating plan.
    Primary Outcome Measure Information:
    Title
    blood glucose in mg/dL
    Description
    A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure glucose concentrations
    Time Frame
    Change from baseline blood glucose concentrations after two weeks.
    Title
    Insulin in uIL/mL
    Description
    A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure insulin concentrations
    Time Frame
    Change from baseline insulin concentrations after two weeks.
    Title
    Insulin-like growth factor-1 in ng/mL
    Description
    A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure insulin-like growth factor-1 concentrations
    Time Frame
    Change from baseline Insulin-like growth factor-1 concentrations after two weeks.
    Title
    Insulin-like growth factor binding protein-3 in mg/L
    Description
    A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure insulin-like growth factor binding protein-3 concentrations
    Time Frame
    Change from baseline insulin-like growth factor binding protein-3 concentrations after two weeks.
    Secondary Outcome Measure Information:
    Title
    Changes in Acne specific quality of life among participants following a low glycemic load diet or their usual diet for two weeks.
    Description
    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.
    Time Frame
    Change in baseline quality of life after two weeks.
    Other Pre-specified Outcome Measures:
    Title
    Changes in nutrition self efficacy among participants following a low glycemic load diet or their usual diet for two weeks
    Description
    Nutrition self-efficacy, or the ability to make diet changes, will be measured using a validated questionnaire.
    Time Frame
    Change in nutrition self-efficacy after two-weeks.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kathleen Woolf, PhD
    Organizational Affiliation
    New York University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jennifer Burris, PhD
    Organizational Affiliation
    New York University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23438493
    Citation
    Burris J, Rietkerk W, Woolf K. Acne: the role of medical nutrition therapy. J Acad Nutr Diet. 2013 Mar;113(3):416-430. doi: 10.1016/j.jand.2012.11.016.
    Results Reference
    background
    PubMed Identifier
    29691143
    Citation
    Burris J, Shikany JM, Rietkerk W, Woolf K. A Low Glycemic Index and Glycemic Load Diet Decreases Insulin-like Growth Factor-1 among Adults with Moderate and Severe Acne: A Short-Duration, 2-Week Randomized Controlled Trial. J Acad Nutr Diet. 2018 Oct;118(10):1874-1885. doi: 10.1016/j.jand.2018.02.009. Epub 2018 Apr 22.
    Results Reference
    derived

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

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