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

M

Maharishi International University

Status

Completed

Conditions

Type 2 Diabetes Mellitus (T2DM)

Treatments

Behavioral: Maharishi Ayurveda Lifestyle Program

Study type

Interventional

Funder types

Other

Identifiers

NCT07400276
Approval 2025_02_8

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

Ayurveda Lifestyle Program
Experimental group
Description:
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.
Treatment:
Behavioral: Maharishi Ayurveda Lifestyle Program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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