An interventional study of SWW Method® Dietary and Lifestyle Intervention in Metabolic Syndrome, Obesity & Overweight and Blood Glucose Monitoring, sponsored by Sarah Wragge Wellness. Completed at 1 site in United States. Open to female participants aged 35 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Sarah Wragge Wellness · Not applicable, Interventional, and Prevention
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.
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.
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This study's enrollment of 85 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
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Exclusion Criteria:
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.
Behavioral: SWW Method® Dietary and Lifestyle 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.
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.
Change in Body Weight
Change in body weight (lbs) from baseline to 12 weeks, measured at Quest Diagnostics
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 12 weeks
Change in LDL Cholesterol
Change in low-density lipoprotein cholesterol (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel
Time frame: 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
Time frame: Baseline and 12 weeks
Change in Triglycerides
Change in triglycerides (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 12 weeks
Change in Waist Circumference
Change in waist circumference (inches) from baseline to 12 weeks, measured at Quest Diagnostics
Time frame: 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
Time frame: Baseline and 12 weeks
Plan to share: 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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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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