Polycystic Ovary SyndromeACESNCT01079845
A Cooking and Eating Study
A study testing Nutrition Education, Dietary Counseling, and Cooking in people with Polycystic Ovary Syndrome, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Background. The polycystic ovary syndrome (PCOS) is a complex hormonal disorder that presents in susceptible girls around the time of menarche. Females with PCOS have high levels of androgens (e.g., testosterone). Read more about this study
- Who is it for?
- Ages 13 to 21 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Nutrition Education, Dietary Counseling, and Cooking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Nov 2013
- 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 13 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of PCOS.
- Aged 13 to 21 years (and living at home with a parent, only for those <18 years old).
- Body mass index (BMI) at or above the 85th percentile.
- Access to a working telephone.
- At least one parent willing and able to participate in the intervention, only for those <18 years old.
- Residing in predominately one household (no more than one weekend every two weeks in a secondary household).
- Medical clearance from the physician who is treating PCOS.
Who cannot join
- Physician diagnosis of a major medical illness or eating disorder.
- Fasting blood glucose at or above 126 mg/dL, indicating diabetes mellitus.
- Chronic use of any medication that may affect study outcomes.
- Current smoking.
- Physical, mental, or cognitive handicaps that prevent participation.
- Sister participating in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Low-glycemic Load vs. Low-fat Diet for Treating PCOS in Obese Adolescents and Young Adults
Background. The polycystic ovary syndrome (PCOS) is a complex hormonal disorder that presents in susceptible girls around the time of menarche. Females with PCOS have high levels of androgens (e.g., testosterone). While cosmetic appearance (excess facial hair and acne) and menstrual disturbances were once considered the primary concerns, emerging data indicate that many adolescents and young adults with PCOS are insulin resistant and at increased risk for metabolic syndrome and diabetes. The majority of females with PCOS are obese, and excess body fat amplifies the severity of the syndrome.
Dietary intervention is considered an important component of treatment for PCOS. However, a consensus statement regarding optimal nutrient composition for treating adolescents and young adults with PCOS has not been published because data are lacking to provide a foundation for such a statement. Recognizing increased risk for diabetes in patients with PCOS, many practitioners employ a low-fat diet as prescribed in the Diabetes Prevention Program (DPP) for weight loss and control of symptoms.
Read more
Objective and Hypothesis. The purpose of this research study is to compare different diets for treating PCOS. We hypothesize that a low-glycemic load diet - designed to lower blood levels of glucose and insulin - will be more beneficial than a low-fat diet in obese adolescents and young adults with PCOS.
Design. We propose a 6-month study in which 50 obese females with PCOS (ages 13 to 21 years) will be assigned to receive one of two dietary treatments, with the goal of retaining 40 participants. Group assignment will be at random. One of the treatments will be a low-glycemic load diet, and the other treatment will be a low-fat diet (modeled after the DPP diet). Participants in both groups will receive individual nutrition education and dietary counseling with a registered dietitian (clinic visits, telephone calls) and cooking workshops with a chef. The purpose of the cooking workshops will be to enhance compliance with diet prescriptions, beyond what can be achieved by nutrition education and dietary counseling in a conventional clinic setting.
The primary outcome will be bioavailable testosterone (form of testosterone that causes symptoms of PCOS). Secondary outcomes will include other blood tests to evaluate further high androgen levels (total testosterone, free testosterone, sex hormone binding globulin, dehydroepiandrosterone sulfate), clinical signs of high androgen levels (excess facial hair, acne), glucose tolerance and risk for diabetes (determined by blood sugar and insulin measurements), risk for cardiovascular disease (based on blood cholesterol and C-reactive protein levels and blood pressure), body fat percentage and distribution (measured using state-of-the-art dual energy x-ray absorptiometry and waist circumference), menstrual cyclicity, and health-related quality of life (evaluated by questionnaire).
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Nutrition Education, Dietary Counseling, and Cooking
- Keywords
- Diet, Nutrition, Adolescent, Young Adult, Overweight, Obesity
- Medical subject headings
- Polycystic Ovary Syndrome, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Education, Dietary Counseling, and CookingBehavioural
Monthly clinic visits with a dietitian, Monthly telephone calls with a dietitian, Three cooking workshops with a chef
| Study group | Role | What they receive |
|---|---|---|
| Low-glycemic Load Diet | Experimental | Not described Receives: Behavioral: Nutrition Education, Dietary Counseling, and Cooking |
| Low-fat Diet | Active comparator | Not described Receives: Behavioral: Nutrition Education, Dietary Counseling, and Cooking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailable Testosterone
Measured: Baseline, 6 months
Secondary outcomes (6)
Other Biochemical and Clinical Signs of Hyperandrogenism
total and free testosterone, sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), hirsutism, acne
Measured: Baseline, 6 months
Insulin Sensitivity and Beta-cell Function
frequently-sampled oral glucose tolerance test, HbA1c
Measured: Baseline, 6 months
Risk for Cardiovascular Disease
serum levels of HDL cholesterol, LDL cholesterol, triglycerides, and C-reactive protein; blood pressure
Measured: Baseline, 6 months
Body Weight and Composition
body fat percentage and distribution assessed by dual-energy x-ray absorptiometry (DXA), waist circumference
Measured: Baseline, 6 months
Cyclicity of Menstrual Periods
Measured: Monthly
Quality of Life
Questionnaire
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: For this pilot, we constructed conditional power curves and noted that we would not substantially enhance power by enrolling additional participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Principal investigator, Cara Ebbeling, Boston Children's Hospital
- Investigators
- Cara B. Ebbeling, PhD, MS, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079845
- Sponsor's protocol ID
- 10-02-0069
- Acronym
- ACES
- Status last verified
- Feb 2015
- First submitted
- 2 Mar 2010
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ebbeling CB, Leidig MM, Feldman HA, Lovesky MM, Ludwig DS. Effects of a low-glycemic load vs low-fat diet in obese young adults: a randomized trial. JAMA. 2007 May 16;297(19):2092-102. doi: 10.1001/jama.297.19.2092.
PubMed 17507345Ebbeling CB, Leidig MM, Sinclair KB, Hangen JP, Ludwig DS. A reduced-glycemic load diet in the treatment of adolescent obesity. Arch Pediatr Adolesc Med. 2003 Aug;157(8):773-9. doi: 10.1001/archpedi.157.8.773.
PubMed 12912783Palmert MR, Gordon CM, Kartashov AI, Legro RS, Emans SJ, Dunaif A. Screening for abnormal glucose tolerance in adolescents with polycystic ovary syndrome. J Clin Endocrinol Metab. 2002 Mar;87(3):1017-23. doi: 10.1210/jcem.87.3.8305.
PubMed 11889155
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-glycemic Load vs. Low-fat Diet for Treating PCOS in Obese Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT01079845
- Acronym / sponsor ID
- ACES / 10-02-0069
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Diet, Nutrition, Adolescent, Young Adult, Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For this pilot, we constructed conditional power curves and noted that we would not substantially enhance power by enrolling additional participants.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Jul 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 3 Mar 2010 (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.
Background. The polycystic ovary syndrome (PCOS) is a complex hormonal disorder that presents in susceptible girls around the time of menarche. Females with PCOS have high levels of androgens (e.g., testosterone). While cosmetic appearance (excess facial hair and acne) and menstrual disturbances were once considered the primary concerns, emerging data indicate that many adolescents and young adults with PCOS are insulin resistant and at increased risk for metabolic syndrome and diabetes. The majority of females with PCOS are obese, and excess body fat amplifies the severity of the syndrome.
Dietary intervention is considered an important component of treatment for PCOS. However, a consensus statement regarding optimal nutrient composition for treating adolescents and young adults with PCOS has not been published because data are lacking to provide a foundation for such a statement. Recognizing increased risk for diabetes in patients with PCOS, many practitioners employ a low-fat diet as prescribed in the Diabetes Prevention Program (DPP) for weight loss and control of symptoms.
Objective and Hypothesis. The purpose of this research study is to compare different diets for treating PCOS. We hypothesize that a low-glycemic load diet - designed to lower blood levels of glucose and insulin - will be more beneficial than a low-fat diet in obese adolescents and young adults with PCOS.
Design. We propose a 6-month study in which 50 obese females with PCOS (ages 13 to 21 years) will be assigned to receive one of two dietary treatments, with the goal of retaining 40 participants. Group assignment will be at random. One of the treatments will be a low-glycemic load diet, and the other treatment will be a low-fat diet (modeled after the DPP diet). Participants in both groups will receive individual nutrition education and dietary counseling with a registered dietitian (clinic visits, telephone calls) and cooking workshops with a chef. The purpose of the cooking workshops will be to enhance compliance with diet prescriptions, beyond what can be achieved by nutrition education and dietary counseling in a conventional clinic setting.
The primary outcome will be bioavailable testosterone (form of testosterone that causes symptoms of PCOS). Secondary outcomes will include other blood tests to evaluate further high androgen levels (total testosterone, free testosterone, sex hormone binding globulin, dehydroepiandrosterone sulfate), clinical signs of high androgen levels (excess facial hair, acne), glucose tolerance and risk for diabetes (determined by blood sugar and insulin measurements), risk for cardiovascular disease (based on blood cholesterol and C-reactive protein levels and blood pressure), body fat percentage and distribution (measured using state-of-the-art dual energy x-ray absorptiometry and waist circumference), menstrual cyclicity, and health-related quality of life (evaluated by questionnaire).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-glycemic Load Diet | Experimental | Behavioral: Nutrition Education, Dietary Counseling, and Cooking |
| Low-fat Diet | Active comparator | Behavioral: Nutrition Education, Dietary Counseling, and Cooking |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Diagnosis of PCOS.
- Aged 13 to 21 years (and living at home with a parent, only for those <18 years old).
- Body mass index (BMI) at or above the 85th percentile.
- Access to a working telephone.
- At least one parent willing and able to participate in the intervention, only for those <18 years old.
Key exclusion criteria (6 listed)
- Physician diagnosis of a major medical illness or eating disorder.
- Fasting blood glucose at or above 126 mg/dL, indicating diabetes mellitus.
- Chronic use of any medication that may affect study outcomes.
- Current smoking.
- Physical, mental, or cognitive handicaps that prevent participation.
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 |
|---|---|---|
| Nutrition Education, Dietary Counseling, and CookingMonthly clinic visits with a dietitian, Monthly telephone calls with a dietitian, Three cooking workshops with a chef | Behavioural | Low-fat Diet, Low-glycemic Load Diet |
Primary outcome
Bioavailable Testosterone
Time frame: Baseline, 6 months
6 secondary outcomes
Other Biochemical and Clinical Signs of Hyperandrogenism
Time frame: Baseline, 6 months
Insulin Sensitivity and Beta-cell Function
Time frame: Baseline, 6 months
Risk for Cardiovascular Disease
Time frame: Baseline, 6 months
Body Weight and Composition
Time frame: Baseline, 6 months
Cyclicity of Menstrual Periods
Time frame: Monthly
Quality of Life
Time frame: Baseline, 6 months
Results and safety
The study was stopped early (reason given: For this pilot, we constructed conditional power curves and noted that we would not substantially enhance power by enrolling additional participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
- Background: PubMed 17507345Ebbeling CB, Leidig MM, Feldman HA, Lovesky MM, Ludwig DS. Effects of a low-glycemic load vs low-fat diet in obese young adults: a randomized trial. JAMA. 2007 May 16;297(19):2092-102. doi: 10.1001/jama.297.19.2092.
- Background: PubMed 12912783Ebbeling CB, Leidig MM, Sinclair KB, Hangen JP, Ludwig DS. A reduced-glycemic load diet in the treatment of adolescent obesity. Arch Pediatr Adolesc Med. 2003 Aug;157(8):773-9. doi: 10.1001/archpedi.157.8.773.
- Background: PubMed 11889155Palmert MR, Gordon CM, Kartashov AI, Legro RS, Emans SJ, Dunaif A. Screening for abnormal glucose tolerance in adolescents with polycystic ovary syndrome. J Clin Endocrinol Metab. 2002 Mar;87(3):1017-23. doi: 10.1210/jcem.87.3.8305.
Related trials for Polycystic Ovary Syndrome
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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Active, not recruiting
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Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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Active, not recruitingObservational study
Association Between Polycystic Ovary Syndrome and Sleep Quality: A Questionnaire-Based Study
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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.
Cara B. Ebbeling, PhD, MS principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education, Dietary Counseling, and Cooking in people with Polycystic Ovary Syndrome, run by Boston Children's Hospital at 1 site in United States.
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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: For this pilot, we constructed conditional power curves and noted that we would not substantially enhance power by enrolling additional participants.). Results are not available in the source record.
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?
Bioavailable Testosterone (time frame: Baseline, 6 months). 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 NCT01079845, which also lists 3 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 5 Feb 2015.