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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913001
• Other study ID #: New York University
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: November 2015

Study information

• Verified date: September 2016
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Other:
• Low Glycemic Load Diet
Participants received a diet education on a low glycemic load diet.
• Usual Eating Plan
Participants received a diet education to continue with their usual eating plan.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
New York University	Nutrisystem, Inc.

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in nutrition self efficacy among participants following a low glycemic load diet or their usual diet for 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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.	Change in baseline quality of life after two weeks.