Type 2 Diabetes Mellitus (T2DM)AYU-LIFE-T2DNCT07400276
Ayurveda Diet & Lifestyle Protocol for Type 2 Diabetes: A Feasibility Study
A study testing Maharishi Ayurveda Lifestyle Program in people with Type 2 Diabetes Mellitus (T2DM), run by Maharishi International University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Maharishi Ayurveda Lifestyle Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2025to 3 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Family Health Centers
Asheville, North Carolina, 28801
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Maharishi Ayurveda Lifestyle Program
- Keywords
- Ayurveda, Type 2 Diabetes Mellitus, Diet & Lifestyle Intervention, Maharishi Yoga Asanas, Bhramari Pranayama, Feasibility Study
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maharishi Ayurveda Lifestyle ProgramBehavioural
Also called Ayurvedic Diabetic Diet and Reset (DDR) Plan, Maharishi Yoga Asanas, Bhramari Pranayama
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Maharishi Ayurveda Lifestyle Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, and 12 weeks
Secondary outcomes (5)
Change in Hemoglobin A1c (HbA1c)
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.
Measured: Baseline and 12 weeks
Change in Fasting Blood Glucose (FBG)
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.
Measured: Baseline, 2, 4, 6, 8, 10, and 12 weeks
Change in Body Weight (in lbs.)
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.
Measured: Baseline and 12 weeks
Change in Body Waist Circumference (WC)
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.
Measured: Baseline and 12 weeks
Change in Body Mass Index (BMI)
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).
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start2 May 2025
- Primary completion22 Aug 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amandeep Negi, Maharishi International University
- Investigators
- Amandeep Negi, BAMS, MHA, Principal investigator, Maharishi International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400276
- Sponsor's protocol ID
- Approval 2025_02_8
- Acronym
- AYU-LIFE-T2D
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 18326601Koenigsberg MR, Corliss J. Diabetes Self-Management: Facilitating Lifestyle Change. Am Fam Physician. 2017 Sep 15;96(6):362-370.
PubMed 28925635Marcy 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.
PubMed 22127765
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ayurveda-inspired Diet and Lifestyle Intervention for Glycemic, Anthropometric, and Stress Improvements in Type 2 Diabetes: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07400276
- Acronym / sponsor ID
- AYU-LIFE-T2D / Approval 2025_02_8
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Ayurveda, Type 2 Diabetes Mellitus, Diet & Lifestyle Intervention, Maharishi Yoga Asanas, Bhramari Pranayama, Feasibility Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Maharishi International UniversityUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ayurveda Lifestyle Program | Experimental | Behavioral: Maharishi Ayurveda Lifestyle ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maharishi Ayurveda Lifestyle ProgramAlso: Ayurvedic Diabetic Diet and Reset (DDR) Plan, Maharishi Yoga Asanas, Bhramari PranayamaA 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. | Behavioural | Ayurveda Lifestyle Program |
Primary outcome
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.
5 secondary outcomes
Change in Hemoglobin A1c (HbA1c)
Time frame: Baseline and 12 weeks
Change in Fasting Blood Glucose (FBG)
Time frame: Baseline, 2, 4, 6, 8, 10, and 12 weeks
Change in Body Weight (in lbs.)
Time frame: Baseline and 12 weeks
Change in Body Waist Circumference (WC)
Time frame: Baseline and 12 weeks
Change in Body Mass Index (BMI)
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 18326601Barclay 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.
- Background: PubMed 28925635Koenigsberg MR, Corliss J. Diabetes Self-Management: Facilitating Lifestyle Change. Am Fam Physician. 2017 Sep 15;96(6):362-370.
- Background: PubMed 22127765Marcy 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amandeep Negi, BAMS, MHA principal investigator
Maharishi International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maharishi Ayurveda Lifestyle Program in people with Type 2 Diabetes Mellitus (T2DM), run by Maharishi International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health Habits Assessment Scale (HHAS) Score (time frame: Baseline, 6 weeks, and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07400276, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.