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

Not Applicable

Completed

• Conditions: Acne Vulgaris
• Interventions: Other: Low Glycemic Load Diet; Other: Usual Eating Plan

• Registration Number: NCT02913001
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-09
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-09
• Study First Submitted: 2016-09-03
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-23
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Glycemic Load Diet	Low Glycemic Load Diet	Participants received a diet education to follow a low glycemic load diet and received some low glycemic load staple foods.
Usual Eating Plan	Usual Eating Plan	Participants received a diet education to continue with their usual diet.

Primary Outcome Measures

Name	Time	Method
Insulin in uIL/mL	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
blood glucose in mg/dL	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
Insulin-like growth factor binding protein-3 in mg/L	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
Insulin-like growth factor-1 in ng/mL	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

Secondary Outcome Measures

Name	Time	Method
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.	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.