The Effect of a Low Glycemic Load Diet on Hormonal Marker... | NCT02913001

NCT02913001

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Nutrisystem, Inc.	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Low Glycemic Load Diet	Other	Participants received a diet education on a low glycemic load diet.	Low Glycemic Load Diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Other Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Name	Affiliation	Role
Kathleen Woolf, PhD	New York University	Principal Investigator
Jennifer Burris, PhD	New York University	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23438493	Background	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.
29691143	Derived	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.

IPD Sharing Statement Module

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases