Diet, Carbohydrate-RestrictedCurves2NCT03093792
Effects of Diet Manipulation on Women in the Curves Program
A study testing American Heart Association plus exercise, Curves Complete - I plus exercise and Curves Complete - II plus exercise in people with Diet, Carbohydrate-Restricted, run by Texas A&M University.
Trial summary
The purpose of this study is to look at the effects of a carbohydrate restricted, high protein, high fat diet on weight loss and health outcomes in women participating in the Curves Fitness and Weight Loss 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, Carbohydrate-Restricted
- What is being tested?
- American Heart Association plus exercise, Curves Complete - I plus exercise and Curves Complete - II plus exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2013to 1 May 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 participate in a regular moderate exercise program
About this study
Official title: Effects of a Carbohydrate Restricted, High Protein, High Fat Diet on Weight Loss and Health Outcomes in Women Participating in the Curves Fitness and Weight Loss Program
The purpose of this study is to look at the effects of a carbohydrate restricted, high protein, high fat diet on weight loss and health outcomes in women participating in the Curves Fitness and Weight Loss Program.
Read the detailed description
The purpose of this study is to determine if a carbohydrate restricted, high protein, high fat diet (20% carbohydrate, 45% protein, 35% fat; CC-II) promotes more favorable changes in weight loss and health outcomes compared to a traditional high carbohydrate, low protein, low fat diet (55% carbohydrate, 15% protein, 30% fat; AHA) and the Curves moderate carbohydrate restricted, high protein, and low fat diet (30% carbohydrate, 45% protein, 25% fat; CC-I).
- Conditions
- Diet, Carbohydrate-Restricted
- Being tested
- Control, American Heart Association plus exercise, Curves Complete - I plus exercise, Curves Complete - II plus exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
American Heart Association plus exerciseOther
Curves Complete - I plus exerciseOther
Curves Complete - II plus exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | (no diet or exercise intervention) Receives: Other: Control |
| American Heart Association | Experimental | (AHA: 55% carbohydrate, 15% protein, 30% fat - diet plus exercise) Receives: Other: American Heart Association plus exercise |
| Curves Complete - I | Active comparator | (CC - I: 30% carbohydrate, 45% protein, 25% fat - diet plus exercise) Receives: Other: Curves Complete - I plus exercise |
| Curves Complete - II | Active comparator | (CC - II: 20% carbohydrate, 45% protein, 35% fat - diet plus exercise) Receives: Other: Curves Complete - II plus exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of the Curves program on physical activity patterns
Measured: 24 weeks
Effects of the Curves program on body weight
Measured: 24 weeks
Effects of the Curves program on the hip/waist ratio
Measured: 24 weeks
Effects of the Curves program on Resting Energy Expenditure (REE)
Measured: 24 weeks
Effects of the Curves program on Blood Pressure (BP)
Measured: 24 weeks
Effects of the Curves program on Heart Rate (HR)
Measured: 24 weeks
Effects of the Curves program on body composition (DXA)
Measured: 24 weeks
Effects of the Curves program on Bioelectrical Impedance Analysis (BIA)
Measured: 24 weeks
Effects of the Curves program on a chemistry-15 blood panel
Measured: 24 weeks
Effects of the Curves program on a cell blood count (CBC) blood panel
Measured: 24 weeks
Effects of the Curves program on lipid panels
Measured: 24 weeks
Secondary outcomes (3)
Effects of the Curves program on maximal cardiopulmonary capacity
Measured: 24 weeks
Effects of the Curves program on muscular strength through a 1 repetition maximum (1 RM) test
Measured: 24 weeks
Effects of the Curves program on muscular endurance through a maximal repetition test
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 posted28 Mar 2017
- Study start1 Sep 2013
- Primary completion1 May 2015
- Study completion1 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, Carbohydrate-RestrictedStudies 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
- 86 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
- NCT03093792
- Sponsor's protocol ID
- IRB2013-0495FX
- Acronym
- Curves2
- Status last verified
- Mar 2017
- First submitted
- 22 Mar 2017
- Last updated
- 28 Mar 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 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Carbohydrate Restricted, High Protein, High Fat Diet on Weight Loss and Health Outcomes in Women Participating in the Curves Fitness and Weight Loss Program
- ClinicalTrials.gov ID
- NCT03093792
- Acronym / sponsor ID
- Curves2 / IRB2013-0495FX
- Conditions
- Diet, Carbohydrate-Restricted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Curves International
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 1 May 2015 (actual)
- First posted
- 28 Mar 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 look at the effects of a carbohydrate restricted, high protein, high fat diet on weight loss and health outcomes in women participating in the Curves Fitness and Weight Loss Program.
Detailed description
The purpose of this study is to determine if a carbohydrate restricted, high protein, high fat diet (20% carbohydrate, 45% protein, 35% fat; CC-II) promotes more favorable changes in weight loss and health outcomes compared to a traditional high carbohydrate, low protein, low fat diet (55% carbohydrate, 15% protein, 30% fat; AHA) and the Curves moderate carbohydrate restricted, high protein, and low fat diet (30% carbohydrate, 45% protein, 25% fat; CC-I).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Control(no diet or exercise intervention) |
| American Heart Association | Experimental | Other: American Heart Association plus exercise(AHA: 55% carbohydrate, 15% protein, 30% fat - diet plus exercise) |
| Curves Complete - I | Active comparator | Other: Curves Complete - I plus exercise(CC - I: 30% carbohydrate, 45% protein, 25% fat - diet plus exercise) |
| Curves Complete - II | Active comparator | Other: Curves Complete - II plus exercise(CC - II: 20% carbohydrate, 45% protein, 35% fat - diet plus exercise) |
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 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 |
|---|---|---|
| Control | Other | Control |
| American Heart Association plus exercise | Other | American Heart Association |
| Curves Complete - I plus exercise | Other | Curves Complete - I |
| Curves Complete - II plus exercise | Other | Curves Complete - II |
Primary outcome
Effects of the Curves program on physical activity patterns
Time frame: 24 weeks
Effects of the Curves program on body weight
Time frame: 24 weeks
Effects of the Curves program on the hip/waist ratio
Time frame: 24 weeks
Effects of the Curves program on Resting Energy Expenditure (REE)
Time frame: 24 weeks
Effects of the Curves program on Blood Pressure (BP)
Time frame: 24 weeks
Effects of the Curves program on Heart Rate (HR)
Time frame: 24 weeks
Effects of the Curves program on body composition (DXA)
Time frame: 24 weeks
Effects of the Curves program on Bioelectrical Impedance Analysis (BIA)
Time frame: 24 weeks
Effects of the Curves program on a chemistry-15 blood panel
Time frame: 24 weeks
Effects of the Curves program on a cell blood count (CBC) blood panel
Time frame: 24 weeks
Effects of the Curves program on lipid panels
Time frame: 24 weeks
3 secondary outcomes
Effects of the Curves program on maximal cardiopulmonary capacity
Time frame: 24 weeks
Effects of the Curves program on muscular strength through a 1 repetition maximum (1 RM) test
Time frame: 24 weeks
Effects of the Curves program on muscular endurance through a maximal repetition test
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 28 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Diet, Carbohydrate-Restricted
Recruiting
Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS
PCOS (Polycystic Ovary Syndrome), Insulin Resistance
Recruiting
Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children
Cardiovascular Syndrome, Metabolic
Active, not recruiting
Dietary Strategies for Remission of Type 2 Diabetes
Diabetes Mellitus, Type 2, Overweight and Obesity
Not yet recruiting
Comparing Two Low-Carbohydrate Diets With a Standard Diet in Type 2 Diabetes
Diabete Mellitus, Obesity & Overweight
Enrolling by invitation
Validation of the Snouda Metabolic Score for Phenotyping and Guiding Reversal in Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM), Insulin Resistance
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 American Heart Association plus exercise, Curves Complete - I plus exercise and Curves Complete - II plus exercise in people with Diet, Carbohydrate-Restricted, 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 28 Mar 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. Some participants in this study may receive a placebo. 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 the Curves program on physical activity patterns (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 28 Mar 2017.