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Completed

NCT Number: NCT07400276

Ayurveda Diet & Lifestyle Protocol for 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family Health Centers

Asheville, North Carolina, 28801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Maharishi Ayurveda Lifestyle Program

Behavioral

A 12-week integrative behavioral lifestyle program combining

  • 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;
  • guided Maharishi Yoga Asanas; and
  • 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Maharishi International University

Other

Registry information

Official study title

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

Acronym: AYU-LIFE-T2D

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2026
Registry last updated
Feb 10, 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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