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

Part of paid clinical trials in New York, New York.

Sponsor
Sarah Wragge Wellness
Study ID
NCT07463417
Status
Completed

Conditions

  • Blood Glucose Monitoring
  • Metabolic Syndrome
  • Obesity & Overweight
  • Type 2 Diabetes Prevention

Eligibility Criteria

Sex
FEMALE
Age
35 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
Mar 2026
Primary completion
Jun 6, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
85 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention group (cases)
    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.
  • No Intervention: Control group
    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.

Primary Outcome Measure

Change in Body Weight [ Time Frame: Baseline and 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sarah Wragge WellnessNew YorkNew York10028-

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