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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02913001
Other study ID # New York University
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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