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

NCT ID: NCT02913001

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acne Vulgaris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low Glycemic Load Diet

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

Group Type EXPERIMENTAL

Low Glycemic Load Diet

Intervention Type OTHER

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

Usual Eating Plan

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

Group Type ACTIVE_COMPARATOR

Usual Eating Plan

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low Glycemic Load Diet

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

Intervention Type OTHER

Usual Eating Plan

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nutrisystem, Inc.

INDUSTRY

Sponsor Role collaborator

New York University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kathleen Woolf, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University

Jennifer Burris, PhD

Role: STUDY_DIRECTOR

New York University

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23438493 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29691143 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

New York University

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Medifast 5 & 1 Plan
NCT01211301 COMPLETED NA