Effect of a Pulse-based USDA-diet on Healthspan

Study Overview
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Brief Summary
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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 to prevent muscle wasting in older adults 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. Using the investigator's published workflow related to all proposed aspects here, the goal is to systematically elucidate for the first time the effects of a lacto-vegetarian DGA 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.

Official Title
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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

Conditions
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Healthy Lifestyle

Intervention / Treatment
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* Other: Meat based
* Other: Pulse based


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: generally good health status based on one routine physical in the past 15 months, current health status normal HbA1C, weigh 110 lb or more Age 60 years or more, generally healthy, all races and both sexes generally practicing a meat-based dietary pattern, do not have any special dietary requirement, and willingness to comply with the study protocol, including on-site meal consumption and sample/data collection. Exclusion Criteria: medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight. 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 nutritional supplements, alcohol, non-study foods, and beverage during the study period.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Meat based<br>Animal protein-based dietary intervention | Other: Meat based<br>* Omnivorous diet following dietary guidelines<br>|
| Experimental: Pulse based<br>Pulse-protein-based dietary intervention | Other: Pulse based<br>* Vegetarian pulse-based diet following dietary guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of TMAO in blood | Using LC/MS based method method | 16 weeks | 
| Fasting blood glucose concentration in blood | Using Glucometer | 16 weeks | 
| Frequency of sit/stand using Chair rise test | Functional assessment | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| HOMA-IR index using insulin and glucose concentration in blood | Standard equation | 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 | 
| Gut microbiota composition and diversity | 16S rRNA gene sequencing | 16 weeks | 
| Concentration of IL-6 in blood | Microplate assay | 16 weeks | 
| Concentration of HsCRP in blood | Microplate assay | 16 weeks | 
| Vascular age score, calculated using lipid markers in blood | Standard equation | 16 weeks | 
| Body weight in kilograms | Measurement | 16 weeks | 
| Fat and lean mass in kg using DXA for body composition measures | DEXA scan | 16 weeks | 
| Muscle strength using Isokinetic muscle testing | Biodex ergometer | 16 weeks | 
| Balance assessment using balance and gait score | Mechanography | 16 weeks | 
| Grip force per kg mass | using Dynamometer | 16 weeks | 
| Concentration of Zonulin | Microplate | 16 weeks | 
| Heart rate (beats per minute) | Upper arm cuff | 16 weeks | 
| Blood pressure in mm Hg | Upper arm cuff | 16 weeks |