Protein-Distinct Macronutrient-Equivalent Diet 1

NCT ID: NCT05577858

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2025-12-31

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Meat based

Animal protein-based dietary intervention

Group Type: OTHER

Meat based

Intervention Type: OTHER

Omnivorous diet following dietary guidelines

Pulse based

Pulse-protein-based dietary intervention

Group Type: EXPERIMENTAL

Pulse based

Intervention Type: OTHER

Lacto-ovo-vegetarian pulse-based diet following dietary guidelines

Interventions

Meat based

Omnivorous diet following dietary guidelines

Intervention Type: OTHER

Pulse based

Lacto-ovo-vegetarian pulse-based diet following dietary guidelines

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

South Dakota State University

OTHER

Sponsor Role: lead

Responsible Party

Moul Dey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moul Dey, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

South Dakota State University

Locations

South Dakota State University, Wagner Hall 416

Brookings, South Dakota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40291832 (View on PubMed)

Other Identifiers

IRB-2209011-EXP

Identifier Type: -

Identifier Source: org_study_id