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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meat based | Other | Animal protein-based dietary intervention |
|
| Pulse based | Experimental | Pulse-protein-based dietary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meat based | Other | Omnivorous diet following dietary guidelines |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ferritin | Microplate assay | 16 weeks |
| Concentration of TMAO in blood | Using LC/MS based method method | 16 weeks |
| Fasting blood glucose concentration in blood | Using Glucometer | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight in kilograms | Measurement | 16 weeks |
| Concentration of CRP in blood | Microplate assay | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moul Dey, Ph.D. | South Dakota State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Dakota State University, Wagner Hall 416 | Brookings | South Dakota | 57007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42162614 | Derived | 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 May 19;74:103337. doi: 10.1016/j.clnesp.2026.103337. Online ahead of print. | |
| 40291832 | Derived |
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Blinding will be implemented to the extent possible. A researcher, unaware of the study goals and not involved with downstream data analyses will use a 1:1 block randomization to allocate participants to the diets in the first arm. Food service personnel (care provider) will not be aware of study goals and allocations. Metabolomic assays will be run in a blinded manner.
| Pulse based |
| Other |
Lacto-ovo-vegetarian pulse-based diet following dietary guidelines |
|
| Gut microbiota composition and diversity | 16S rRNA gene sequencing | 16 weeks |
| Fat and lean mass in kg using DXA for body composition measures | DEXA scan | 16 weeks |
| Concentration of sulfur containing amino acids in blood | LC/MS based method | 16 weeks |
| Digestible indispensable amino acid score using different amino acid concentrations | Using standard equation | 16 weeks |
| Concentration of IGF-1 in blood | Using Microplate assay kit | 16 weeks |
| Concentration of IGF-BP3 in blood | Using Microplate assay kit | 16 weeks |
| Concentration of Fasting insulin in blood | Using Microplate assay kit | 16 weeks |
| Peak heights of several complex lipids panel using metabolomics technique | LC/MS based assay | 16 weeks |
| Concentration Short-chain fatty acid panel in stool | using LC/MS based assay | 16 weeks |
| Peak heights of several Biogenic amines panel using metabolomics technique | using LC/MS based assay | 16 weeks |
| Muscle strength using Isokinetic muscle testing | Biodex ergometer | 16 weeks |
| Balance assessment using balance | Mechanography | 16 weeks |
| Grip force per kg mass | using Dynamometer | 16 weeks |
| Blood pressure in mm Hg | Upper arm cuff | 16 weeks |
| de 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. |