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Completed

NCT Number: NCT02913001

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Glycemic Load Diet

Other

Participants received a diet education on a low glycemic load diet.

Usual Eating Plan

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

New York University

Other

Collaborators

  • Nutrisystem, Inc.

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2016
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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