Metabolic SyndromeNCT07463417
Evaluating the SWW Method Dietary Intervention for HbA1c and Weight Management as a Preventative Intervention in Women
A study testing SWW Method® Dietary and Lifestyle Intervention in people with Metabolic Syndrome and Obesity & Overweight, run by Sarah Wragge Wellness at 1 site in United States.
Trial summary
This study evaluated the SWW Method®, a 12-week dietary and lifestyle intervention based on the carbohydrate-insulin model, in a healthy cohort of women aged 35-75. The study assessed whether the intervention resulted in significant improvements in blood glucose markers (HbA1c, fasting blood glucose), weight, BMI, and… Read more about this study
- Who is it for?
- Ages 35 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity & Overweight, Blood Glucose Monitoring
- What is being tested?
- SWW Method® Dietary and Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 31 Aug 2025
- 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 35 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- 35-75 years of age
- No prior enrollment in the SWW Method® or Sarah Wragge Wellness® program.
Who cannot join
- History of non-skin-related cancer diagnosis or treatment within the past five years.
- Currently taking weight loss medication, including semaglutide
- Currently taking any medication for blood sugar or diabetes management.
- Previous enrollment in the SWW Method® or any Sarah Wragge Wellness® program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the SWW Method® Dietary Intervention for HbA1c and Weight Management as a Preventative Intervention in Women
This study evaluated the SWW Method®, a 12-week dietary and lifestyle intervention based on the carbohydrate-insulin model, in a healthy cohort of women aged 35-75. The study assessed whether the intervention resulted in significant improvements in blood glucose markers (HbA1c, fasting blood glucose), weight, BMI, and other metabolic markers compared to a no-intervention control group. The SWW Method® protocol includes intermittent fasting, a protein-forward diet, meal sequencing, hydration, magnesium supplementation, and sleep support. This was a non-randomized case-control trial with 45 intervention participants and 40 controls, conducted over 12 weeks.
Read the detailed description
The SWW Method® study is a non-randomized case-control trial in which participants self-selected into either the SWW Method® intervention group (cases) or a no-intervention control group through separate recruitment channels. Primary, secondary, and exploratory outcome measures were compared between the two groups.
This 12-week trial was designed to evaluate the SWW Method®'s effect on blood sugar balance and weight loss in a moderately healthy population of women aged 35-75. Cases completed the six-week SWW Method® program, followed by six weeks of coach-supported accountability via the ATE™ app. Questionnaires and lab work were collected one week before and six weeks after the intervention to assess changes over the 12-week period.
The SWW Method® is an isocaloric carbohydrate-insulin model (CIM)-based protocol designed to support blood sugar balance and weight loss through: adequate hydration, alkalizing with a daily greens powder, intermittent fasting, conscious meal timing, a protein-forward diet, non-starchy vegetables with every meal, limiting starchy carbohydrate intake to once per day, magnesium supplementation, and optimizing circadian rhythm. The protocol is delivered through nutrition education, group coaching, and one-on-one nutrition support.
Participants completed a Comprehensive Health Profile through Quest Diagnostics at baseline and 12 weeks, including a complete blood count (CBC), comprehensive metabolic panel (CMP), lipid/cholesterol panel, urinalysis, hemoglobin A1c (HbA1c), vitamin D, and high-sensitivity C-reactive protein (hsCRP), as well as biometrics including height, weight, waist circumference, and blood pressure.
The primary outcome was change in HbA1c / fasting blood glucose and weight / BMI between baseline and 12 weeks. Secondary outcomes included changes in lipid markers, blood pressure, C-reactive protein, and other lab and biometric measures. Statistical analysis was performed using the Wilcoxon signed-rank test for within-group comparisons and difference-in-differences regression for between-group comparisons.
- Conditions
- Metabolic Syndrome, Obesity & Overweight, Blood Glucose Monitoring, Type 2 Diabetes Prevention
- Being tested
- SWW Method® Dietary and Lifestyle Intervention
- Keywords
- Carbohydrate-insulin model, Blood sugar balance, Weight loss, HbA1c, Intermittent fasting, Preventative nutrition, Dietary intervention, Women's health, Metabolic health, Case-control trial
- Medical subject headings
- Metabolic Syndrome, Obesity, Overweight, Weight Loss, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWW Method® Dietary and Lifestyle InterventionBehavioural
A 12-week isocaloric dietary and lifestyle intervention based on the carbohydrate-insulin model (CIM), including: morning hydration, alkalizing with a dehydrated greens powder, intermittent fasting (12-16 hours overnight), conscious meal timing, a protein-forward diet (30+ grams per meal), non-starchy vegetables with every meal, limiting starchy carbohydrates to once per day, magnesium supplementation, and sleep support. Delivered through weekly group coaching calls, one-on-one nutrition coaching, daily food logging via the ATE™ app, and access to nutrition education materials.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (cases) | Experimental | Participants enrolled in the 12-week SWW Method® dietary and lifestyle intervention program. During the first six weeks, cases completed the SWW Method® program including a structured nutrition protocol, one-on-one coaching, group coaching calls, daily food logging via the ATE™ app, and supplementation with SWW Alkalize® and SWW Restore®. During the final six weeks, participants received continued coach access and nutrition education materials to support ongoing adherence. Receives: Behavioral: SWW Method® Dietary and Lifestyle Intervention |
| Control group | No intervention | Participants received no dietary or lifestyle intervention. Controls completed the same baseline and follow-up questionnaires and lab testing at identical timepoints as the intervention group for comparison purposes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Change in body weight (lbs) from baseline to 12 weeks, measured at Quest Diagnostics
Measured: Baseline and 12 weeks
Change in HbA1c Time Frame: Baseline and 12 weeks
Change in hemoglobin A1c (%) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile
Measured: Baseline and 12 weeks
Change in BMI
Change in body mass index from baseline to 12 weeks, calculated from height and weight measured at Quest Diagnostics
Measured: Baseline and 12 weeks
Change in Fasting Blood Glucose
Change in fasting blood glucose (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile following 8-12 hour fast
Measured: Baseline and 12 weeks
Secondary outcomes (8)
Change in LDL Cholesterol
Change in low-density lipoprotein cholesterol (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel
Measured: Baseline and 12 weeks
Change in HDL Cholesterol
Change in high-density lipoprotein cholesterol (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel
Measured: Baseline and 12 weeks
Change in Triglycerides
Change in triglycerides (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel
Measured: Baseline and 12 weeks
Change in Total Cholesterol
Change in total cholesterol (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel
Measured: Baseline and 12 weeks
Change in hsCRP
Change in high-sensitivity C-reactive protein (mg/L) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile
Measured: Baseline and 12 weeks
Change in Blood Pressure
Change in systolic and diastolic blood pressure (mmHg) from baseline to 12 weeks, measured at Quest Diagnostics
Measured: Baseline and 12 weeks
Change in Waist Circumference
Change in waist circumference (inches) from baseline to 12 weeks, measured at Quest Diagnostics
Measured: Baseline and 12 weeks
Change in Vitamin D
Change in serum vitamin D (ng/mL) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 Apr 2024
- Primary completion6 Jun 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized case-control trial in which participants self-selected into either the SWW Method® dietary and lifestyle intervention group (cases) or a no-intervention control group through separate recruitment channels.
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Wragge Wellness
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Megan B Grover, Sarah Wragge Wellness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463417
- Sponsor's protocol ID
- Pro00077176
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to privacy and ethical restrictions. The data supporting the findings of this study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the SWW Method® Dietary Intervention for HbA1c and Weight Management as a Preventative Intervention in Women
- ClinicalTrials.gov ID
- NCT07463417
- Acronym / sponsor ID
- Pro00077176
- Conditions
- Metabolic Syndrome, Obesity & Overweight, Blood Glucose Monitoring, Type 2 Diabetes Prevention
- Keywords
- Carbohydrate-insulin model, Blood sugar balance, Weight loss, HbA1c, Intermittent fasting, Preventative nutrition, Dietary intervention, Women's health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Sarah Wragge WellnessIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 11 Mar 2026 (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.
This study evaluated the SWW Method®, a 12-week dietary and lifestyle intervention based on the carbohydrate-insulin model, in a healthy cohort of women aged 35-75. The study assessed whether the intervention resulted in significant improvements in blood glucose markers (HbA1c, fasting blood glucose), weight, BMI, and other metabolic markers compared to a no-intervention control group. The SWW Method® protocol includes intermittent fasting, a protein-forward diet, meal sequencing, hydration, magnesium supplementation, and sleep support. This was a non-randomized case-control trial with 45 intervention participants and 40 controls, conducted over 12 weeks.
Detailed description
The SWW Method® study is a non-randomized case-control trial in which participants self-selected into either the SWW Method® intervention group (cases) or a no-intervention control group through separate recruitment channels. Primary, secondary, and exploratory outcome measures were compared between the two groups.
This 12-week trial was designed to evaluate the SWW Method®'s effect on blood sugar balance and weight loss in a moderately healthy population of women aged 35-75. Cases completed the six-week SWW Method® program, followed by six weeks of coach-supported accountability via the ATE™ app. Questionnaires and lab work were collected one week before and six weeks after the intervention to assess changes over the 12-week period.
The SWW Method® is an isocaloric carbohydrate-insulin model (CIM)-based protocol designed to support blood sugar balance and weight loss through: adequate hydration, alkalizing with a daily greens powder, intermittent fasting, conscious meal timing, a protein-forward diet, non-starchy vegetables with every meal, limiting starchy carbohydrate intake to once per day, magnesium supplementation, and optimizing circadian rhythm. The protocol is delivered through nutrition education, group coaching, and one-on-one nutrition support.
Participants completed a Comprehensive Health Profile through Quest Diagnostics at baseline and 12 weeks, including a complete blood count (CBC), comprehensive metabolic panel (CMP), lipid/cholesterol panel, urinalysis, hemoglobin A1c (HbA1c), vitamin D, and high-sensitivity C-reactive protein (hsCRP), as well as biometrics including height, weight, waist circumference, and blood pressure.
The primary outcome was change in HbA1c / fasting blood glucose and weight / BMI between baseline and 12 weeks. Secondary outcomes included changes in lipid markers, blood pressure, C-reactive protein, and other lab and biometric measures. Statistical analysis was performed using the Wilcoxon signed-rank test for within-group comparisons and difference-in-differences regression for between-group comparisons.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized case-control trial in which participants self-selected into either the SWW Method® dietary and lifestyle intervention group (cases) or a no-intervention control group through separate recruitment channels.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (cases) | Experimental | Behavioral: SWW Method® Dietary and Lifestyle InterventionParticipants enrolled in the 12-week SWW Method® dietary and lifestyle intervention program. During the first six weeks, cases completed the SWW Method® program including a structured nutrition protocol, one-on-one coaching, group coaching calls, daily food logging via the ATE™ app, and supplementation with SWW Alkalize® and SWW Restore®. During the final six weeks, participants received continued coach access and nutrition education materials to support ongoing adherence. |
| Control group | No intervention | –Participants received no dietary or lifestyle intervention. Controls completed the same baseline and follow-up questionnaires and lab testing at identical timepoints as the intervention group for comparison purposes. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- 35-75 years of age
- No prior enrollment in the SWW Method® or Sarah Wragge Wellness® program.
Key exclusion criteria (4 listed)
- History of non-skin-related cancer diagnosis or treatment within the past five years.
- Currently taking weight loss medication, including semaglutide
- Currently taking any medication for blood sugar or diabetes management.
- Previous enrollment in the SWW Method® or any Sarah Wragge Wellness® 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 |
|---|---|---|
| SWW Method® Dietary and Lifestyle InterventionA 12-week isocaloric dietary and lifestyle intervention based on the carbohydrate-insulin model (CIM), including: morning hydration, alkalizing with a dehydrated greens powder, intermittent fasting (12-16 hours overnight), conscious meal timing, a protein-forward diet (30+ grams per meal), non-starchy vegetables with every meal, limiting starchy carbohydrates to once per day, magnesium supplementation, and sleep support. Delivered through weekly group coaching calls, one-on-one nutrition coaching, daily food logging via the ATE™ app, and access to nutrition education materials. | Behavioural | Intervention group (cases) |
Primary outcome
Change in Body Weight
Time frame: Baseline and 12 weeks
Change in body weight (lbs) from baseline to 12 weeks, measured at Quest Diagnostics
Change in HbA1c Time Frame: Baseline and 12 weeks
Time frame: Baseline and 12 weeks
Change in hemoglobin A1c (%) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile
Change in BMI
Time frame: Baseline and 12 weeks
Change in body mass index from baseline to 12 weeks, calculated from height and weight measured at Quest Diagnostics
Change in Fasting Blood Glucose
Time frame: Baseline and 12 weeks
Change in fasting blood glucose (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile following 8-12 hour fast
8 secondary outcomes
Change in LDL Cholesterol
Time frame: Baseline and 12 weeks
Change in HDL Cholesterol
Time frame: Baseline and 12 weeks
Change in Triglycerides
Time frame: Baseline and 12 weeks
Change in Total Cholesterol
Time frame: Baseline and 12 weeks
Change in hsCRP
Time frame: Baseline and 12 weeks
Change in Blood Pressure
Time frame: Baseline and 12 weeks
Change in Waist Circumference
Time frame: Baseline and 12 weeks
Change in Vitamin D
Time frame: Baseline and 12 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 12 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to privacy and ethical restrictions. The data supporting the findings of this study are available from the corresponding author upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SWW Method® Dietary and Lifestyle Intervention in people with Metabolic Syndrome and Obesity & Overweight, run by Sarah Wragge Wellness 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 3 inclusion and 4 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 12 Mar 2026. 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 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?
Change in Body Weight (time frame: Baseline and 12 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?
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 12 Mar 2026.