Clinical trial NCT05577858: Protein-Distinct Macronutrient-Equivalent Diet 1
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Lifestyle
Lead sponsor: South Dakota State University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 76
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Ferritin
timeFrame: 16 weeks
measure: Concentration of TMAO in blood
timeFrame: 16 weeks
measure: Fasting blood glucose concentration in blood
timeFrame: 16 weeks
Secondary outcomes:
measure: Body weight in kilograms
timeFrame: 16 weeks
measure: Concentration of CRP in blood
timeFrame: 16 weeks
measure: Gut microbiota composition and diversity
timeFrame: 16 weeks
measure: Fat and lean mass in kg using DXA for body composition measures
timeFrame: 16 weeks
measure: Concentration of sulfur containing amino acids in blood
timeFrame: 16 weeks
measure: Digestible indispensable amino acid score using different amino acid concentrations
timeFrame: 16 weeks
measure: Concentration of IGF-1 in blood
timeFrame: 16 weeks
measure: Concentration of IGF-BP3 in blood
timeFrame: 16 weeks
measure: Concentration of Fasting insulin in blood
timeFrame: 16 weeks
measure: Peak heights of several complex lipids panel using metabolomics technique
timeFrame: 16 weeks
measure: Concentration Short-chain fatty acid panel in stool
timeFrame: 16 weeks
measure: Peak heights of several Biogenic amines panel using metabolomics technique
timeFrame: 16 weeks
measure: Muscle strength using Isokinetic muscle testing
timeFrame: 16 weeks
measure: Balance assessment using balance
timeFrame: 16 weeks
measure: Grip force per kg mass
timeFrame: 16 weeks
measure: Blood pressure in mm Hg
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Brookings
country: United States
facility: South Dakota State University, Wagner Hall 416
state: South Dakota
Study officials:
affiliation: South Dakota State University
name: Moul Dey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: