Diet ModificationCurves3NCT03116711
Effects of Diet Selection Based on Genetic Screening on Success to a Weight Loss Program
A study testing Positive CIQ plus High Carbohydrate Diet, Positive CIQ plus High Protein Diet and Negative CIQ plus High Carbohydrate Diet in people with Diet Modification, run by Texas A&M University.
Trial summary
The purpose of this study is to determine the effects of diet type selection based on response to a Carbohydrate Intolerance Questionnaire (CIQ) and genetic screening on success to a weight loss and exercise program. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diet Modification
- What is being tested?
- Positive CIQ plus High Carbohydrate Diet, Positive CIQ plus High Protein Diet and Negative CIQ plus High Carbohydrate Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2013to 1 Jul 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant is an apparently healthy female
- The participant is between the ages of 18 and 60
Who cannot join
- The participant is pregnant or nursing, or plans to become pregnant during the next 12 months or has been pregnant in the past 12 months
- The participant has uncontrolled metabolic disorder including known electrolyte abnormalities; heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease
- The participant is currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications
- The participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB), anabolic/catabolic hormone levels (androstenedione, DHEA, etc.) or weight loss (e.g., ephedra, thermogenics, etc.) within the past three months
- The participant is willing to take participate in a regular moderate exercise program
About this study
Official title: Effects of Diet Type Selection Based on Response to a Carbohydrate Intolerance Questionnaire and Genetic Screening on Success to a Weight Loss and Exercise Program
The purpose of this study is to determine the effects of diet type selection based on response to a Carbohydrate Intolerance Questionnaire (CIQ) and genetic screening on success to a weight loss and exercise program.
Read the detailed description
The purpose of this study is to determine if stratification of individuals based on responses to a Carbohydrate Intolerance Questionnaire (CIQ), genetic screening, and/or DNA methylation affects weight loss success and/or health outcomes of women following the Curves moderate carbohydrate, high protein, low fat diet (30% carbohydrate, 45% protein, 25% fat) or the Curves carbohydrate restricted, high protein, moderate fat diet (20% carbohydrate, 45% protein, 35% fat).
- Conditions
- Diet Modification
- Being tested
- Positive CIQ plus High Carbohydrate Diet, Positive CIQ plus High Protein Diet, Negative CIQ plus High Carbohydrate Diet, Negative CIQ plus High Protein Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive CIQ plus High Carbohydrate DietOther
Positive Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet
Positive CIQ plus High Protein DietOther
Positive Carbohydrate Intolerance Questionnaire plus High Protein Diet
Negative CIQ plus High Carbohydrate DietOther
Negative Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet
Negative CIQ plus High Protein DietOther
Negative Carbohydrate Intolerance Questionnaire plus High Protein Diet
| Study group | Role | What they receive |
|---|---|---|
| Positive CIQ plus High Carbohydrate Diet | Active comparator | Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet Receives: Other: Positive CIQ plus High Carbohydrate Diet |
| Positive CIQ plus High Protein Diet | Active comparator | Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet Receives: Other: Positive CIQ plus High Protein Diet |
| Negative CIQ plus High Carbohydrate Diet | Active comparator | Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet Receives: Other: Negative CIQ plus High Carbohydrate Diet |
| Negative CIQ plus High Protein Diet | Active comparator | Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet Receives: Other: Negative CIQ plus High Protein Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of diet selection on physical activity patterns changes (steps per day)
Measured: 24 weeks
Effects of diet selection on body weight changes (pounds)
Measured: 24 weeks
Effects of diet selection on hip/waist ratio changes (inches)
Measured: 24 weeks
Effects of diet selection on Resting Energy Expenditure (REE) changes (calories per day)
Measured: 24 weeks
Effects of diet selection on Blood Pressure (BP) changes (mmHG)
Measured: 24 weeks
Effects of diet selection on Heart Rate (HR) changes (beats per minute)
Measured: 24 weeks
Effects of diet selection on body composition (DXA) changes (percent fat mass)
Measured: 24 weeks
Effects of diet selection on Bioelectrical Impedance Analysis (BIA) changes (flow impedance)
Measured: 24 weeks
Effects of diet selection on a chemistry-15 blood panel changes
Measured: 24 weeks
Effects of diet selection on a cell blood count (CBC) blood panel changes
Measured: 24 weeks
Effects of diet selection on lipid panel changes
Measured: 24 weeks
Secondary outcomes (5)
Effects of diet selection on maximal cardiopulmonary capacity changes (ml/kg/min)
Measured: 24 weeks
Effects of diet selection on muscular strength through a 1 repetition maximum (1 RM) test
Measured: 24 weeks
Effects of diet selection on muscular endurance through a maximal repetition test
Measured: 24 weeks
Effects of diet selection on gene expression changes
Measured: 24 weeks
Effects of diet selection on DNA methylation changes
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start1 Nov 2013
- Primary completion1 Jul 2015
- Study completion1 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Curves International
- Responsible party
- Sponsor
- Investigators
- Richard B Kreider, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116711
- Sponsor's protocol ID
- IRB2013-0737F
- Acronym
- Curves3
- Status last verified
- Mar 2017
- First submitted
- 29 Mar 2017
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diet Type Selection Based on Response to a Carbohydrate Intolerance Questionnaire and Genetic Screening on Success to a Weight Loss and Exercise Program
- ClinicalTrials.gov ID
- NCT03116711
- Acronym / sponsor ID
- Curves3 / IRB2013-0737F
- Conditions
- Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Curves International
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 17 Apr 2017 (actual)
- 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.
The purpose of this study is to determine the effects of diet type selection based on response to a Carbohydrate Intolerance Questionnaire (CIQ) and genetic screening on success to a weight loss and exercise program.
Detailed description
The purpose of this study is to determine if stratification of individuals based on responses to a Carbohydrate Intolerance Questionnaire (CIQ), genetic screening, and/or DNA methylation affects weight loss success and/or health outcomes of women following the Curves moderate carbohydrate, high protein, low fat diet (30% carbohydrate, 45% protein, 25% fat) or the Curves carbohydrate restricted, high protein, moderate fat diet (20% carbohydrate, 45% protein, 35% fat).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Positive CIQ plus High Carbohydrate Diet | Active comparator | Other: Positive CIQ plus High Carbohydrate DietPositive Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet |
| Positive CIQ plus High Protein Diet | Active comparator | Other: Positive CIQ plus High Protein DietPositive Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet |
| Negative CIQ plus High Carbohydrate Diet | Active comparator | Other: Negative CIQ plus High Carbohydrate DietNegative Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet |
| Negative CIQ plus High Protein Diet | Active comparator | Other: Negative CIQ plus High Protein DietNegative Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The participant is an apparently healthy female
- The participant is between the ages of 18 and 60
Key exclusion criteria (5 listed)
- The participant is pregnant or nursing, or plans to become pregnant during the next 12 months or has been pregnant in the past 12 months
- The participant has uncontrolled metabolic disorder including known electrolyte abnormalities; heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease
- The participant is currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications
- The participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB), anabolic/catabolic hormone levels (androstenedione, DHEA, etc.) or weight loss (e.g., ephedra, thermogenics, etc.) within the past three months
- The participant is willing to take participate in a regular moderate exercise program
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 |
|---|---|---|
| Positive CIQ plus High Carbohydrate DietPositive Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet | Other | Positive CIQ plus High Carbohydrate Diet |
| Positive CIQ plus High Protein DietPositive Carbohydrate Intolerance Questionnaire plus High Protein Diet | Other | Positive CIQ plus High Protein Diet |
| Negative CIQ plus High Carbohydrate DietNegative Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet | Other | Negative CIQ plus High Carbohydrate Diet |
| Negative CIQ plus High Protein DietNegative Carbohydrate Intolerance Questionnaire plus High Protein Diet | Other | Negative CIQ plus High Protein Diet |
Primary outcome
Effects of diet selection on physical activity patterns changes (steps per day)
Time frame: 24 weeks
Effects of diet selection on body weight changes (pounds)
Time frame: 24 weeks
Effects of diet selection on hip/waist ratio changes (inches)
Time frame: 24 weeks
Effects of diet selection on Resting Energy Expenditure (REE) changes (calories per day)
Time frame: 24 weeks
Effects of diet selection on Blood Pressure (BP) changes (mmHG)
Time frame: 24 weeks
Effects of diet selection on Heart Rate (HR) changes (beats per minute)
Time frame: 24 weeks
Effects of diet selection on body composition (DXA) changes (percent fat mass)
Time frame: 24 weeks
Effects of diet selection on Bioelectrical Impedance Analysis (BIA) changes (flow impedance)
Time frame: 24 weeks
Effects of diet selection on a chemistry-15 blood panel changes
Time frame: 24 weeks
Effects of diet selection on a cell blood count (CBC) blood panel changes
Time frame: 24 weeks
Effects of diet selection on lipid panel changes
Time frame: 24 weeks
5 secondary outcomes
Effects of diet selection on maximal cardiopulmonary capacity changes (ml/kg/min)
Time frame: 24 weeks
Effects of diet selection on muscular strength through a 1 repetition maximum (1 RM) test
Time frame: 24 weeks
Effects of diet selection on muscular endurance through a maximal repetition test
Time frame: 24 weeks
Effects of diet selection on gene expression changes
Time frame: 24 weeks
Effects of diet selection on DNA methylation changes
Time frame: 24 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 17 Apr 2017.
- 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.
Richard B Kreider, PhD principal investigator
Texas A&M University
Questions about this trial
What is this clinical trial studying?
A study testing Positive CIQ plus High Carbohydrate Diet, Positive CIQ plus High Protein Diet and Negative CIQ plus High Carbohydrate Diet in people with Diet Modification, run by Texas A&M 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 2 inclusion and 5 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 17 Apr 2017. 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?
Effects of diet selection on physical activity patterns changes (steps per day) (time frame: 24 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2017.