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

October 31, 2022 updated by: New York University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline blood glucose concentrations after two weeks.
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
Change from baseline insulin concentrations after two weeks.
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
Change from baseline Insulin-like growth factor-1 concentrations after two weeks.
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
Change from baseline insulin-like growth factor binding protein-3 concentrations after two weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in baseline quality of life after two weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in nutrition self-efficacy after two-weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York University

Collaborators

Nutrisystem, Inc.

Investigators

  • Principal Investigator: Kathleen Woolf, PhD, New York University
  • Study Director: Jennifer Burris, PhD, New York University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

September 3, 2016

First Submitted That Met QC Criteria

September 21, 2016

First Posted (ESTIMATE)

September 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • New York University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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