Ayurveda Diet & Lifestyle Protocol for Type 2 Diabetes: A Feasibility Study (AYU-LIFE-T2D)

February 6, 2026 updated by: Amandeep Negi, Maharishi International University

Ayurveda-inspired Diet and Lifestyle Intervention for Glycemic, Anthropometric, and Stress Improvements in Type 2 Diabetes: A Feasibility Study

This study looked at whether a 12-week Maharishi Ayurveda diet and lifestyle program was practical and acceptable for adults with Type 2 Diabetes. The program was offered through Family Health Centers in North Carolina and combined three parts: an Ayurvedic-based diet plan, guided yoga postures, and a breathing practice.

Seventeen participants started the program, and twelve completed the full 12- week intervention. The study focused on whether participants were able to follow the program regularly, complete study activities, and stay in the study for the full period. Participants were asked to practice the program at least five days per week and received regular support through scheduled and as-needed communication via phone, text messages, email, and video-based materials throughout the study.

The study also tracked changes in daily health habits, blood sugar levels, body weight, waist size, stress, and diabetes-related emotional well-being. Some information was collected using questionnaires, and some measurements were taken through clinic visits or home glucose monitoring.

Most participants who completed the program were able to follow the activities as instructed. Changes were observed in blood sugar levels, body weight, waist size, and measures of stress and diabetes-related distress. No serious safety concerns were reported.

Overall, the study showed that this Ayurvedic diet and lifestyle program could be safely carried out in a primary care setting. The results support further research with larger groups to better understand its potential benefits over time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and Rationale:

Type 2 Diabetes Mellitus (T2DM) is a chronic condition influenced by both genetic and modifiable lifestyle factors, including diet, physical inactivity, stress, and obesity. In the United States, diabetes prevalence has increased substantially over the past two decades, in part due to lifestyle-related factors. Although pharmacological therapies are widely used, long-term diabetes management remains challenging because of adherence difficulties, side effects, and psychosocial burden. Integrative lifestyle approaches that incorporate dietary regulation, physical activity, and stress-reduction practices may support diabetes self-management; however, their feasibility and acceptability within U.S. primary care settings require further evaluation.

Study Objective The primary objective of this study was to assess the feasibility, acceptability, and safety of a 12-week Maharishi Ayurveda-inspired diet and lifestyle program for adults with T2DM. The study aimed to evaluate participant adherence, program completion, and the practicality of implementing this multi-component intervention in a real-world primary care context.

Study Design This was a single-arm feasibility study conducted at Family Health Centers in North Carolina, USA. Adults with a diagnosis of T2DM were recruited from the clinic population. Seventeen participants initiated the intervention, and twelve completed the full 12-week program.

Intervention Overview

Participants received a structured 12-week lifestyle intervention consisting of three integrated components:

Dietary Component The Ayurvedic Diabetic Diet and Reset (DDR) Plan emphasized low-glycemic-index food choices, meal regularity, and dietary patterns aligned with Ayurvedic principles of digestive balance and broader health-related lifestyle behaviors. The plan focused on food categories, preparation methods, and meal timing rather than caloric prescription. During the dietary reset phase (approximately Weeks 1-8), participants were progressively introduced to core DDR principles, food lists, and simplified recipes to support gradual dietary transition and feasibility. Study-specific recipes and educational materials were delivered through recorded video modules.

Physical Activity Component Maharishi Yoga Asanas (MYA) consisted of a standardized sequence of physical postures designed to support physical mobility, circulation, and stress regulation. Participants were trained using video-based instruction and received remote guidance as needed throughout the intervention period.

Breathing Practice Bhramari Pranayama, a slow humming breath practice, was included to support stress regulation. Participants were instructed to practice daily following Maharishi Yoga Asanas, beginning with approximately five minutes per session and progressing to ten minutes over the course of the intervention.

Adherence Monitoring and Support Participants were instructed to engage in the intervention components at least five days per week. Daily engagement was self-monitored using SMART (Self-Monitoring and Review Tracking) log sheets, which were completed daily and submitted to the study team every two weeks. Adherence support and clarification were provided through scheduled text messages and phone calls approximately every one to two weeks, with additional communication as needed. Intervention materials were delivered digitally. Participants used home glucometers to self-monitor fasting blood glucose, with readings reported biweekly during the intervention period.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Family Health Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Adults aged 18 to 70 years
  • Diagnosed with Type 2 Diabetes Mellitus
  • Hemoglobin A1c between 6.5% and 9.5%
  • Receiving primary care at the Family Health Centers in North Carolina
  • Stable oral diabetes medication regimen for at least 3 months prior to enrollment
  • Able and willing to follow the study diet, yoga, and breathing practices
  • Able to communicate in English
  • Able to provide informed consent

Exclusion Criteria

  • Diagnosis of Type 1 Diabetes
  • Current use of insulin
  • Recent changes in diabetes medications within the past 3 months
  • Pregnant or breastfeeding
  • Uncontrolled psychiatric illness that would interfere with participation
  • Physical limitations that prevent participation in yoga or movement practices
  • History of eating disorders
  • Allergy or strong aversion to foods used in the study diet
  • Participation in another lifestyle or intervention study during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ayurveda Lifestyle Program
Participants in this single-arm feasibility study received a 12-week Maharishi Ayurveda-based lifestyle program that integrated dietary and lifestyle guidance, yoga-based physical activity, and breathing practices. All participants assigned to this arm received the same intervention and were followed for feasibility, adherence, and health-related outcomes.
Behavioral: Maharishi Ayurveda Lifestyle Program

A 12-week integrative behavioral lifestyle program combining

  1. an Ayurvedic Diabetic Diet and Reset (DDR) Plan emphasizing low-glycemic-index food choices, meal regularity, and health-related lifestyle behaviors aligned with Ayurvedic principles;
  2. guided Maharishi Yoga Asanas; and
  3. daily Bhramari Pranayama breathing practice. The program was supported through scheduled phone and text check-ins.
Other Names:
  • Ayurvedic Diabetic Diet and Reset (DDR) Plan
  • Maharishi Yoga Asanas
  • Bhramari Pranayama

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Health Habits Assessment Scale (HHAS) Score
Time Frame: Baseline, 6 weeks, and 12 weeks
The HHAS is a self-report measure developed to assess participant engagement in health-promoting habits, including dietary choices, physical activity, daily routine, and stress-reduction practices. In this study, it was used to evaluate the feasibility and behavioral adherence to the Maharishi Ayurveda-based lifestyle program. Participants completed the HHAS at baseline, mid-, and post-intervention.
Baseline, 6 weeks, and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin A1c (HbA1c)
Time Frame: Baseline and 12 weeks
HbA1c was measured in a CLIA-certified lab at the Family Health Centers at baseline and after 12 weeks to assess longer-term glycemic control. This was a key clinical biomarker for evaluating the physiological impact of the diet & lifestyle intervention.
Baseline and 12 weeks
Change in Fasting Blood Glucose (FBG)
Time Frame: Baseline, 2, 4, 6, 8, 10, and 12 weeks
FBG was assessed through CLIA-certified laboratory tests at baseline and at 12 weeks. Additionally, participants used home glucometers to measure FBG at 2, 4, 6, 8, 10, and 12 weeks. These combined measures were used to evaluate short-term glycemic response to the lifestyle intervention.
Baseline, 2, 4, 6, 8, 10, and 12 weeks
Change in Body Weight (in lbs.)
Time Frame: Baseline and 12 weeks
Body weight was measured in pounds (lbs.) and converted to kilograms (kg) for analysis. Measurements were taken using standard calibrated clinical scales at the Family Health Centers.
Baseline and 12 weeks
Change in Body Waist Circumference (WC)
Time Frame: Baseline and 12 weeks
Waist circumference was measured (in inches) at baseline and 12 weeks to assess changes in anthropometric indicators associated with metabolic health. Measurements were taken using standard clinical tools at the Family Health Centers.
Baseline and 12 weeks
Change in Body Mass Index (BMI)
Time Frame: Baseline and 12 weeks
Body Mass Index (BMI) was calculated using height and weight measurements obtained by Family Health Centers' clinical staff at baseline and post-intervention. BMI values were expressed in kilograms per square meter (kg/m²).
Baseline and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Perceived Stress Scale-10 (PSS-10) Score
Time Frame: Baseline, 6 weeks, and 12 weeks
The Perceived Stress Scale-10 (PSS-10) is a validated questionnaire used to measure perceived stress levels over the past month. Participants completed the scale at baseline, 6 weeks, and 12 weeks to evaluate psychological changes during the 12-week Ayurvedic lifestyle intervention.
Baseline, 6 weeks, and 12 weeks
Change in Problem Areas in Diabetes (PAID) Score
Time Frame: Baseline, 6 weeks, and 12 weeks
The Problem Areas in Diabetes (PAID) scale is a validated tool assessing emotional distress related to diabetes management. Participants completed the PAID scale at baseline, 6 weeks, and 12 weeks to measure changes in diabetes-related emotional burden over the course of the intervention.
Baseline, 6 weeks, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maharishi International University

Investigators

  • Principal Investigator: Amandeep Negi, BAMS, MHA, Maharishi International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2025

Primary Completion (Actual)

August 22, 2025

Study Completion (Actual)

September 3, 2025

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Approval 2025_02_8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study team intends to publish results in peer-reviewed journals. A final decision about sharing individual participant data (IPD) has not yet been made. Any future sharing will depend on participant consent, IRB approval, and institutional policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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