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Completed

NCT Number: NCT07463417

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.

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Key information

Conditions

Metabolic Syndrome Behavior Blood Glucose Monitoring Body Weight Body Weight Changes Fasting Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Intermittent Fasting Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes Prevention Weight Loss

Age range

35 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sarah Wragge Wellness

New York, 10028, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • 35-75 years of age
  • No prior enrollment in the SWW Method® or Sarah Wragge Wellness® program.

Exclusion criteria

  • 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.

Treatment and study plan

SWW Method® Dietary and Lifestyle Intervention

Behavioral

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.

Primary outcomes

  1. Change in Body Weight

    Time frame: Baseline and 12 weeks

    Change in body weight (lbs) from baseline to 12 weeks, measured at Quest Diagnostics

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Change in LDL Cholesterol

    Time frame: Baseline and 12 weeks

    Change in low-density lipoprotein cholesterol (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel

  2. Change in HDL Cholesterol

    Time frame: Baseline and 12 weeks

    Change in high-density lipoprotein cholesterol (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel

  3. Change in Triglycerides

    Time frame: Baseline and 12 weeks

    Change in triglycerides (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel

  4. Change in Total Cholesterol

    Time frame: Baseline and 12 weeks

    Change in total cholesterol (mg/dL) from baseline to 12 weeks, measured via Quest Diagnostics lipid panel

  5. Change in hsCRP

    Time frame: Baseline and 12 weeks

    Change in high-sensitivity C-reactive protein (mg/L) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile

  6. Change in Blood Pressure

    Time frame: Baseline and 12 weeks

    Change in systolic and diastolic blood pressure (mmHg) from baseline to 12 weeks, measured at Quest Diagnostics

  7. Change in Waist Circumference

    Time frame: Baseline and 12 weeks

    Change in waist circumference (inches) from baseline to 12 weeks, measured at Quest Diagnostics

  8. Change in Vitamin D

    Time frame: Baseline and 12 weeks

    Change in serum vitamin D (ng/mL) from baseline to 12 weeks, measured via Quest Diagnostics Comprehensive Health Profile

Sponsors and collaborators

Lead sponsor

Sarah Wragge Wellness

Industry

Registry information

Official study title

Evaluating the SWW Method® Dietary Intervention for HbA1c and Weight Management as a Preventative Intervention in Women

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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