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

New York University97 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acne Vulgaris

Interventions

Low Glycemic Load DietOTHER

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

Usual Eating PlanOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

blood glucose in mg/dL

A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure glucose concentrations

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Change from baseline insulin-like growth factor binding protein-3 concentrations after two weeks.

Secondary Outcomes

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

Time frame: Change in baseline quality of life after two weeks.

Data from ClinicalTrials.gov

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