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

NCT02913001 | Completed

• 1 other identifier: New York University
• Study Type: interventional
• Target: 97
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne Vulgaris

Keywords

Diet; glycemic index; glycemic load; Acne Vulgaris

Outcome Measures

Primary Outcomes (4)

• blood glucose in mg/dL

  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

  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

  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

  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 Outcomes (1)

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

  Change in baseline quality of life after two weeks.

Other Outcomes (1)

• Changes in nutrition self efficacy among participants following a low glycemic load diet or their usual diet for two weeks

  Change in nutrition self-efficacy after two-weeks.

Study Arms (2)

Low Glycemic Load Diet

EXPERIMENTAL

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

Usual Eating Plan

ACTIVE COMPARATOR

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

Other: Usual Eating Plan

Interventions

Low Glycemic Load Diet OTHER

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

Low Glycemic Load Diet

Usual Eating Plan OTHER

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

Usual Eating Plan

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \> 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.

Sponsors & Collaborators

• New York University: lead
• Nutrisystem, Inc.: collaborator

Related Publications (2)

• 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.

  PMID: 23438493 BACKGROUND

• 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.

  PMID: 29691143 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Kathleen Woolf, PhD

  New York University

  PRINCIPAL INVESTIGATOR

• Jennifer Burris, PhD

  New York University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2016
• First Posted: September 23, 2016
• Study Start: September 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 1, 2022

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share