N/A
N=16
The Role of Altered Nutrient Partitioning in Food Reward
Overweight and Obesity
Bottom Line
View on ClinicalTrials.gov: NCT05200845 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Change in Preference- Liking — 6.5; 4.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Conditioned Stimulus + (CS+): Flavored beverage solution with 75 calories of sucrose (Other); Conditioned Stimulus - (CS-): Flavored beverage solution with sweetness-matched sucralose (Other); High-Fat Test Meal Inside a Metabolic Chamber (Other); High-Carbohydrate Test Meal Inside a Metabolic Chamber (Other); fMRI Scan (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Polytechnic Institute and State University
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Preference- Liking |
6.5; 4.5 | — |
| SECONDARY Post-test Preference - Wanting |
50.6; 47.7 | — |
| SECONDARY Change in Preference- Wanting |
9; 6 | — |
| SECONDARY Change in Preference- Wanting |
9; 6 | — |
| SECONDARY Blood Oxygen Level-dependent (BOLD) Response to Beverages |
0.0615; 0.0467 | — |
| SECONDARY Substrate Oxidation Response to Test Meals |
4.6; -3.5 | — |
| SECONDARY Blood Glucose Response to Beverages |
882.4; 37.9 | — |
| SECONDARY Blood Insulin Response to Beverages |
694.4; 39.2 | — |
| SECONDARY Energy Expenditure in Response to Beverages |
3.11; 0.76 | — |
| SECONDARY Respiratory Exchange Ratio in Response to Beverages |
2.9; 0.8 | — |
| SECONDARY Substrate Oxidation in Response to Beverages |
3.5; 0.9 | — |
Summary
Obesity remains a public health epidemic despite substantial advances in treatment strategies and therapies in the last decade. Effective strategies to support maintenance of improved metabolic health and reduced body weight are still needed.
Signals from the gut to the brain are important in regulating metabolism and energy balance and have been linked with food reward and preference in metabolically healthy individuals with normal body mass index. In particular, post-ingestive signaling related to glucose metabolism has been linked with food reward and preference. However, not much is known about how these gut and brain signals interact to influence eating behaviors in states of obesity or altered metabolic health. In addition, evidence in rodent models and human studies indicates obesity is associated with a blunted brain response to foods compared with normal body weight. However, whether altered nutrient utilization, termed metabolic inflexibility, influences the relationship between obesity and food reward has yet to be studied.
The overall objective of this proof-of-concept pilot study is to assess the feasibility of measuring reward response following a flavor-nutrient conditioning paradigm across the normal to obese body mass index (BMI) range and in states of altered metabolic health. The aims of this study are: 1) to determine whether differences in reinforcement learning/flavor-nutrient conditioning of carbohydrate can be measured across the body mass index range; and 2) to determine the feasibility of assessing metabolic flexibility and whether a relationship between metabolic flexibility and calorie-predictive reward can be detected.
Eligibility Criteria
Inclusion Criteria
- BMI between 18.5-40 kg/m2
- Not pregnant or planning to become pregnant during study participation
- Residing in the Roanoke area and/or willing/able to attend sessions at the Fralin Biomedical Research Institute
- Able to speak and write in English
- Specific to fMRI scan only: BMI between 25-35 kg/m2
Exclusion Criteria
- Current inhaled nicotine use
- History of alcohol dependence.
- Current or past diagnosis of diabetes or thyroid problems.
- Glycated hemoglobin (Hemoglobin A1C) >5.7%
- Taking medications known to influence study measures (including antiglycemic agents, thyroid medications, sleep medications)
- Active medical or neurologic disorder.
- Recent change in body weight (gain or loss of > 5 lbs within the past 3 months)
- Current shift work (typical pattern of work/activity overnight)
- Previous weight loss surgery
- Adherence to a special diet within the past 3 months (e.g., low-carb or ketogenic diet, exclusion of food groups/specific macronutrients, intermittent fasting, etc.)
- Allergy to any food or ingredient included in the study diets, meals, or beverages
- Currently pregnant or planning to become pregnant during study participation
- Claustrophobia
- Contraindications for MRI, including pacemaker, aneurysm clips, neurostimulators, cochlear or other implants, metal in eyes, regular work with steel, etc. (Note: This is an fMRI-specific exclusion criterion. Participants may be allowed to participate in all other study sessions and measures that do not involve fMRI.)
- Contraindications for bioelectrical impedance analysis, specifically implanted devices
Data sourced from ClinicalTrials.gov (NCT05200845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.