Acne VulgarisNCT02913001
The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
A study testing Low Glycemic Load Diet and Usual Eating Plan in people with Acne Vulgaris, run by New York University.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Low Glycemic Load Diet and Usual Eating Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- > 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.
About this study
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Low Glycemic Load Diet, Usual Eating Plan
- Keywords
- Diet, glycemic index, glycemic load, Acne Vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Low Glycemic Load Diet |
| Usual Eating Plan | Active comparator | Participants received a diet education to continue with their usual diet. Receives: Other: Usual Eating Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose in mg/dL
A trained clinician will use venipuncture to draw approximately 30 mL of blood to measure glucose concentrations
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline insulin-like growth factor binding protein-3 concentrations after two weeks.
Secondary outcomes (1)
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.
Measured: Change in baseline quality of life after two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startSep 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrisystem, Inc.
- Responsible party
- Sponsor
- Investigators
- Kathleen Woolf, PhD, Principal investigator, New York UniversityJennifer Burris, PhD, Study director, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913001
- Sponsor's protocol ID
- New York University
- Status last verified
- Sep 2016
- First submitted
- 3 Sep 2016
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23438493Burris 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.
PubMed 29691143
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
- ClinicalTrials.gov ID
- NCT02913001
- Acronym / sponsor ID
- New York University
- Conditions
- Acne Vulgaris
- Keywords
- Diet, glycemic index, glycemic load, Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- Nutrisystem, Inc.
- Study start
- Sep 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Glycemic Load Diet | Experimental | Other: Low Glycemic Load DietParticipants received a diet education to follow a low glycemic load diet and received some low glycemic load staple foods. |
| Usual Eating Plan | Active comparator | Other: Usual Eating PlanParticipants received a diet education to continue with their usual diet. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- > 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Glycemic Load DietParticipants received a diet education on a low glycemic load diet. | Other | Low Glycemic Load Diet |
| Usual Eating PlanParticipants received a diet education to continue with their usual eating plan. | Other | Usual Eating Plan |
Primary outcome
blood glucose in mg/dL
Time frame: 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 in uIL/mL
Time frame: 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
Insulin-like growth factor-1 in ng/mL
Time frame: 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
Insulin-like growth factor binding protein-3 in mg/L
Time frame: 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
1 secondary outcome
Changes in Acne specific quality of life among participants following a low glycemic load diet or their usual diet for two weeks.
Time frame: Change in baseline quality of life after two weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Background: PubMed 23438493Burris 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.
- Derived from this study: PubMed 29691143Burris 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Woolf, PhD principal investigator
New York University
Jennifer Burris, PhD study director
New York University
Questions about this trial
What is this clinical trial studying?
A study testing Low Glycemic Load Diet and Usual Eating Plan in people with Acne Vulgaris, run by New York University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood glucose in mg/dL (time frame: Change from baseline blood glucose concentrations after two weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02913001, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.