Ayurveda Diet & Lifestyle Protocol for Type 2 Diabetes: A Feasibility Study

NCT07400276 | Completed

• 1 other identifier: Approval 2025_02_8
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Ayurveda; Type 2 Diabetes Mellitus; Diet & Lifestyle Intervention; Maharishi Yoga Asanas; Bhramari Pranayama; Feasibility Study

Outcome Measures

Primary Outcomes (1)

• Change in Health Habits Assessment Scale (HHAS) Score

  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 Outcomes (5)

• Change in Hemoglobin A1c (HbA1c)

  Baseline and 12 weeks

• Change in Fasting Blood Glucose (FBG)

  Baseline, 2, 4, 6, 8, 10, and 12 weeks

• Change in Body Weight (in lbs.)

  Baseline and 12 weeks

• Change in Body Waist Circumference (WC)

  Baseline and 12 weeks

• Change in Body Mass Index (BMI)

  Baseline and 12 weeks

Other Outcomes (2)

• Change in Perceived Stress Scale-10 (PSS-10) Score

  Baseline, 6 weeks, and 12 weeks

• Change in Problem Areas in Diabetes (PAID) Score

  Baseline, 6 weeks, and 12 weeks

Study Arms (1)

Ayurveda Lifestyle Program

EXPERIMENTAL

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

Interventions

Maharishi Ayurveda Lifestyle Program BEHAVIORAL

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.

Also known as: Ayurvedic Diabetic Diet and Reset (DDR) Plan, Maharishi Yoga Asanas, Bhramari Pranayama

Ayurveda Lifestyle Program

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maharishi International University: lead

Study Sites (1)

Family Health Centers

Asheville, North Carolina, 28801, United States

Location

Related Publications (3)

• Barclay AW, Petocz P, McMillan-Price J, Flood VM, Prvan T, Mitchell P, Brand-Miller JC. Glycemic index, glycemic load, and chronic disease risk--a meta-analysis of observational studies. Am J Clin Nutr. 2008 Mar;87(3):627-37. doi: 10.1093/ajcn/87.3.627.

  PMID: 18326601 BACKGROUND

• Koenigsberg MR, Corliss J. Diabetes Self-Management: Facilitating Lifestyle Change. Am Fam Physician. 2017 Sep 15;96(6):362-370.

  PMID: 28925635 BACKGROUND

• Marcy TR, Britton ML, Harrison D. Identification of barriers to appropriate dietary behavior in low-income patients with type 2 diabetes mellitus. Diabetes Ther. 2011 Mar;2(1):9-19. doi: 10.1007/s13300-010-0012-6. Epub 2011 Jan 21.

  PMID: 22127765 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Amandeep Negi, BAMS, MHA

  Maharishi International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Researcher

Model Details: This was a single-group feasibility study evaluating the acceptability, adherence, and implementation of a multi-component lifestyle intervention delivered alongside usual medical care. The study was not designed to test comparative efficacy.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 10, 2026
• Study Start: May 2, 2025
• Primary Completion: August 22, 2025
• Study Completion: September 3, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)