Healthy LifestylePRODMED1NCT05577858
Protein-Distinct Macronutrient-Equivalent Diet 1
A study testing Meat based and Pulse based in people with Healthy Lifestyle, run by South Dakota State University at 1 site in United States.
Trial summary
Plant-based diets are naturally low in Methionine (Met), and also low in precursor molecules (e.g L-carnitine, choline, betaine, etc.) producing microbiota-mediated proatherogenic TMAO. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- What is being tested?
- Meat based and Pulse based
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to 20 Dec 2023
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally good health status based on routine physical in the past 12 months, current healthy status
- Normal HbA1C, not underweight
- Age 60 years or more, all races, both sexes and all education level
- Do not have any special dietary requirements and willing to consume vegetarian diet
- Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.
Who cannot join
- Probiotic, long-term antibiotic, and tobacco/drug/alcohol use
- Not on any special diet within 3 months of recruitment
- Impaired kidney functions
- Active history of cancer, diabetes, heart, liver, and kidney diseases
- Major gastrointestinal disorders in the past 3 months
- History of heart attacks or stroke
Show all 10Show fewer
- Unable to meet in-person visit requirements for dining, picking up meals, and tests
- Any mental health condition that would affect the ability to provide written informed consent.
- If they had not had a routine health checkup during the 12 months prior to recruitment.
- If they were unwilling to abstain from taking certain nutritional supplements, alcohol, or non-study foods during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Dakota State University, Wagner Hall 416
Brookings, South Dakota, 57007
About this study
Official title: Effect of a Pulse-based USDA-diet on Gut Microbial Metabolites and Biomarkers of Healthspan: A 18-week Randomized Controlled Crossover Feeding Study in Older Adults
Plant-based diets are naturally low in Methionine (Met), and also low in precursor molecules (e.g L-carnitine, choline, betaine, etc.) producing microbiota-mediated proatherogenic TMAO. Among plant proteins, pulses are rich in micronutrients, and dietary fibers, making them ideal for microbiome-stimulating, nutrient-dense, healthful dietary patterns. However, daily pulse intake remains low at 8% in America despite recommendations by DGA, a resource to guide health promotion across communities. A significant body of preclinical data, waiting to be translated to humans, suggests that dietary Met restriction can trigger beneficial metabolic and anti-inflammatory adaptations leading to improved chronic health and longevity. The central hypothesis is that a pulse-protein-based healthy diet can be simultaneously equivalent to omnivorous diets in protein content and yet naturally lower in Met and TMAO to improve glycemic control, body composition, and immunometabolic flexibility to reduce the risk of chronic diseases and improve healthspan. The goal is to systematically elucidate for the first time the effects of a lacto-vegetarian feeding pattern with pulses as the primary protein source on a comprehensive panel of ~500 traditional and next-generation biomarkers of health, and assess the role of the gut microbiota in mediating such effects. We also aim to interrogate the potential concern about the lower bioavailability of non-heme iron from pulses.
- Conditions
- Healthy Lifestyle
- Being tested
- Meat based, Pulse based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meat basedOther
Omnivorous diet following dietary guidelines
Pulse basedOther
Lacto-ovo-vegetarian pulse-based diet following dietary guidelines
| Study group | Role | What they receive |
|---|---|---|
| Meat based | Other | Animal protein-based dietary intervention Receives: Other: Meat based |
| Pulse based | Experimental | Pulse-protein-based dietary intervention Receives: Other: Pulse based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferritin
Microplate assay
Measured: 16 weeks
Concentration of TMAO in blood
Using LC/MS based method method
Measured: 16 weeks
Fasting blood glucose concentration in blood
Using Glucometer
Measured: 16 weeks
Secondary outcomes (16)
Body weight in kilograms
Measurement
Measured: 16 weeks
Concentration of CRP in blood
Microplate assay
Measured: 16 weeks
Gut microbiota composition and diversity
16S rRNA gene sequencing
Measured: 16 weeks
Fat and lean mass in kg using DXA for body composition measures
DEXA scan
Measured: 16 weeks
Concentration of sulfur containing amino acids in blood
LC/MS based method
Measured: 16 weeks
Digestible indispensable amino acid score using different amino acid concentrations
Using standard equation
Measured: 16 weeks
Concentration of IGF-1 in blood
Using Microplate assay kit
Measured: 16 weeks
Concentration of IGF-BP3 in blood
Using Microplate assay kit
Measured: 16 weeks
Concentration of Fasting insulin in blood
Using Microplate assay kit
Measured: 16 weeks
Peak heights of several complex lipids panel using metabolomics technique
LC/MS based assay
Measured: 16 weeks
Concentration Short-chain fatty acid panel in stool
using LC/MS based assay
Measured: 16 weeks
Peak heights of several Biogenic amines panel using metabolomics technique
using LC/MS based assay
Measured: 16 weeks
Muscle strength using Isokinetic muscle testing
Biodex ergometer
Measured: 16 weeks
Balance assessment using balance
Mechanography
Measured: 16 weeks
Grip force per kg mass
using Dynamometer
Measured: 16 weeks
Blood pressure in mm Hg
Upper arm cuff
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start15 Nov 2022
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy LifestyleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moul Dey, South Dakota State University
- Investigators
- Moul Dey, Ph.D., Principal investigator, South Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577858
- Sponsor's protocol ID
- IRB-2209011-EXP
- Acronym
- PRODMED1
- Status last verified
- Feb 2025
- First submitted
- 7 Oct 2022
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Vargas BO, Vaezi S, Weidauer L, Sanders WM, Dey M. Effects of a pulse-based, guidelines-aligned diet on biomarkers relevant to aging: Results from the PRODMED1 randomized controlled crossover feeding trial. Clin Nutr ESPEN. 2026 Aug;74:103337. doi: 10.1016/j.clnesp.2026.103337. Epub 2026 May 19.
PubMed 42162614de Vargas BO, Vaezi S, Freeling JL, Zhang Y, Weidauer L, Lee CL, Zhao J, Dey M. Design and Implementation of the Protein-Distinct Macronutrient-Equivalent Diet (PRODMED) Study: An Eighteen-Week Randomized Crossover Feeding Trial Among Free-Living Rural Older Adults. Curr Dev Nutr. 2025 Mar 24;9(5):104588. doi: 10.1016/j.cdnut.2025.104588. eCollection 2025 May.
PubMed 40291832
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Pulse-based USDA-diet on Gut Microbial Metabolites and Biomarkers of Healthspan: A 18-week Randomized Controlled Crossover Feeding Study in Older Adults
- ClinicalTrials.gov ID
- NCT05577858
- Acronym / sponsor ID
- PRODMED1 / IRB-2209011-EXP
- Conditions
- Healthy Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- South Dakota State UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 13 Oct 2022 (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.
Plant-based diets are naturally low in Methionine (Met), and also low in precursor molecules (e.g L-carnitine, choline, betaine, etc.) producing microbiota-mediated proatherogenic TMAO. Among plant proteins, pulses are rich in micronutrients, and dietary fibers, making them ideal for microbiome-stimulating, nutrient-dense, healthful dietary patterns. However, daily pulse intake remains low at 8% in America despite recommendations by DGA, a resource to guide health promotion across communities. A significant body of preclinical data, waiting to be translated to humans, suggests that dietary Met restriction can trigger beneficial metabolic and anti-inflammatory adaptations leading to improved chronic health and longevity. The central hypothesis is that a pulse-protein-based healthy diet can be simultaneously equivalent to omnivorous diets in protein content and yet naturally lower in Met and TMAO to improve glycemic control, body composition, and immunometabolic flexibility to reduce the risk of chronic diseases and improve healthspan. The goal is to systematically elucidate for the first time the effects of a lacto-vegetarian feeding pattern with pulses as the primary protein source on a comprehensive panel of ~500 traditional and next-generation biomarkers of health, and assess the role of the gut microbiota in mediating such effects. We also aim to interrogate the potential concern about the lower bioavailability of non-heme iron from pulses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meat based | Other | Other: Meat basedAnimal protein-based dietary intervention |
| Pulse based | Experimental | Other: Pulse basedPulse-protein-based dietary intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Generally good health status based on routine physical in the past 12 months, current healthy status
- Normal HbA1C, not underweight
- Age 60 years or more, all races, both sexes and all education level
- Do not have any special dietary requirements and willing to consume vegetarian diet
- Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.
Key exclusion criteria (10 listed)
- Probiotic, long-term antibiotic, and tobacco/drug/alcohol use
- Not on any special diet within 3 months of recruitment
- Impaired kidney functions
- Active history of cancer, diabetes, heart, liver, and kidney diseases
- Major gastrointestinal disorders in the past 3 months
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 |
|---|---|---|
| Meat basedOmnivorous diet following dietary guidelines | Other | Meat based |
| Pulse basedLacto-ovo-vegetarian pulse-based diet following dietary guidelines | Other | Pulse based |
Primary outcome
Ferritin
Time frame: 16 weeks
Microplate assay
Concentration of TMAO in blood
Time frame: 16 weeks
Using LC/MS based method method
Fasting blood glucose concentration in blood
Time frame: 16 weeks
Using Glucometer
16 secondary outcomes
Body weight in kilograms
Time frame: 16 weeks
Concentration of CRP in blood
Time frame: 16 weeks
Gut microbiota composition and diversity
Time frame: 16 weeks
Fat and lean mass in kg using DXA for body composition measures
Time frame: 16 weeks
Concentration of sulfur containing amino acids in blood
Time frame: 16 weeks
Digestible indispensable amino acid score using different amino acid concentrations
Time frame: 16 weeks
Concentration of IGF-1 in blood
Time frame: 16 weeks
Concentration of IGF-BP3 in blood
Time frame: 16 weeks
Concentration of Fasting insulin in blood
Time frame: 16 weeks
Peak heights of several complex lipids panel using metabolomics technique
Time frame: 16 weeks
Concentration Short-chain fatty acid panel in stool
Time frame: 16 weeks
Peak heights of several Biogenic amines panel using metabolomics technique
Time frame: 16 weeks
Muscle strength using Isokinetic muscle testing
Time frame: 16 weeks
Balance assessment using balance
Time frame: 16 weeks
Grip force per kg mass
Time frame: 16 weeks
Blood pressure in mm Hg
Time frame: 16 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 17 Sep 2026.
- Derived from this study: PubMed 42162614de Vargas BO, Vaezi S, Weidauer L, Sanders WM, Dey M. Effects of a pulse-based, guidelines-aligned diet on biomarkers relevant to aging: Results from the PRODMED1 randomized controlled crossover feeding trial. Clin Nutr ESPEN. 2026 Aug;74:103337. doi: 10.1016/j.clnesp.2026.103337. Epub 2026 May 19.
- Derived from this study: PubMed 40291832de Vargas BO, Vaezi S, Freeling JL, Zhang Y, Weidauer L, Lee CL, Zhao J, Dey M. Design and Implementation of the Protein-Distinct Macronutrient-Equivalent Diet (PRODMED) Study: An Eighteen-Week Randomized Crossover Feeding Trial Among Free-Living Rural Older Adults. Curr Dev Nutr. 2025 Mar 24;9(5):104588. doi: 10.1016/j.cdnut.2025.104588. eCollection 2025 May.
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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.
Moul Dey, Ph.D. principal investigator
South Dakota State 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 Meat based and Pulse based in people with Healthy Lifestyle, run by South Dakota State 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 5 inclusion and 10 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 17 Sep 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?
Ferritin (time frame: 16 weeks). The study lists 3 primary outcomes in all. 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 NCT05577858, which also lists 2 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 17 Sep 2026.