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

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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

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Other: Low Glycemic Load Diet Other: Usual Eating Plan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
Study Start Date : September 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
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.
Other: Low Glycemic Load Diet
Participants received a diet education on a low glycemic load diet.

Active Comparator: Usual Eating Plan
Participants received a diet education to continue with their usual diet.
Other: Usual Eating Plan
Participants received a diet education to continue with their usual eating plan.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT02913001


Sponsors and Collaborators
New York University
Nutrisystem, Inc.
Investigators
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Principal Investigator: Kathleen Woolf, PhD New York University
Study Director: Jennifer Burris, PhD New York University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kathleen Woolf, Assistant Professor, New York University
ClinicalTrials.gov Identifier: NCT02913001     History of Changes
Other Study ID Numbers: New York University
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kathleen Woolf, New York University:
Diet
glycemic index
glycemic load
Acne Vulgaris
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases