NCT06053294: CARB

Neural and Metabolic Factors in Carbohydrate Reward

Recruiting now NA Last updated 11 June 2025

What this trial tests

NA trial testing CS- Beverage in Carbohydrate Metabolism in 64 participants. Currently enrolling.

Timeline

1 May 2023

Primary endpoint
1 May 2028

1 May 2029

Quick facts

Lead sponsor	Virginia Polytechnic Institute and State University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	64
Start date	1 May 2023
Primary completion	1 May 2028
Estimated completion	1 May 2029
Sites	1 location across United States

Drugs / interventions tested

• CS- Beverage
• CS+Fast
• CS+Slow

Conditions studied

• Carbohydrate Metabolism — all drugs for Carbohydrate Metabolism →

Sponsor

Virginia Polytechnic Institute and State University

Who can join

Adults 18 to 45, any sex, with Carbohydrate Metabolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Dietary factors contributed to nearly 50% of all cardiometabolic deaths in the US in 2012, making it one of the leading causes of preventable death in the US, second only to tobacco use. Human diets and food choices can't help but be influenced by the ubiquitous availability of processed foods of high-energy density and low nutrient content, consumption of which can lead to obesity, type II diabetes, heart disease, and other types of metabolic dysfunction. Surprisingly, food reinforcement does not rely on perceived energy density. Rather food reinforcement is associated with actual energy density and therefore, on an implicit knowledge of caloric content. That implicit knowledge must have a neural signature and a mechanism by which the gut communicates nutritive value to the brain. There is evidence, at least for fat and carbohydrates, that these pathways are separable, but terminate in a common neural structure, the dorsal striatum or caudate. This could be one mechanism by which modern processed foods high in both fat and carbohydrate are so sought after and readily consumed, In fact, when experimentally tested, fat and carbohydrate combinations were more reinforcing calorie for calorie than fat or carbohydrates alone and the level of reinforcement correlated with activity in reward- related brain areas. Beyond simple reinforcing value, it is known from the literature on drugs of abuse that the faster a drug is arrives at the brain, the higher it's abuse potential, however, little is known about how the kinetics of nutrient excursion influence food preference, choice, and brain activity. This project aims to test this specifically for carbohydrate reward.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Neural and metabolic factors in carbohydrate reward: Rationale, design, and methods for a flavor-nutrient learning paradigm in humans.
   Kelly AL, Baugh ME, Ahrens ML, Valle AN, et al · · 2024 · PMID 39413990 · DOI 10.1016/j.cct.2024.107717