Impact of the Eating Rate of Ultra-processed Foods on Dietary Intake Behavior and Metabolic Responses
- Conditions
- Eating Rate
- Interventions
- Other: ultra-processed slow eating rate dietOther: Ultra-processed fast eating rate diet
- Registration Number
- NCT06113146
- Lead Sponsor
- Wageningen University
- Brief Summary
The aim of this balanced-order block randomized controlled cross-over trial with 2 treatment arms is to determine the effect of eating rate (ER) of ultra-processed food diets (UPF fast ER vs UPF slow ER) on ad libitum energy intake across a two week period.
- Detailed Description
Rationale: Consumption of industrially processed foods has been associated with obesity and related adverse health outcomes. If this reflects a causal relationship, it is unknown what attributes or properties of industrially processed foods might drive this association. Extensive research has shown that foods consumed with a texture-derived slow eating rate (ER) are consumed in smaller amounts relative to foods consumed with a fast ER. ER has been suggested as one of the mechanisms why (ultra-)processed foods (with a fast ER) may promote excess in calorie intakes. We will therefore test the hypothesis that ER moderates energy intakes from ultra-processed foods.
Objective: The primary objective of this study is to determine the effect of ER of ultra-processed food diets (UPF slow ER vs UPF fast ER) on ad libitum energy intake (kcal/day) across a two week period. The secondary objectives are to compare body composition and metabolic changes that occur when on a 14 day diet of ultra-processed foods with either a slow or a fast ER.
Study design: We will conduct a balanced-order, block randomized controlled cross-over trial with 2 treatment arms, to determine the effect of ER of ultra-processed food diets (UPF fast ER vs UPF slow ER) on ad libitum energy intake (kcal) across a two week period. The study will have a run-in period to determine habitual dietary habits (baseline) and a washout period (14 days) between treatments to prevent carry-over effects. All participants will receive both treatments and are their own control (within subject design).
Study population: 39 healthy, non-smoking, adults between 21-50 years old and with a BMI between 21-27 kg/m2 will be included.
Intervention: The two treatments are 1) a 14-days ultra-processed, slow ER diet, and 2) a 14-days ultra-processed, fast ER diet. The ad libitum meal menus are matched for energy density (kcal/g), liking (hedonic range), and level of processing, but different in textural characteristics known to influence ER. During the treatment periods participants eat all of their main meals at the research site on weekdays. Participants receive pre-packed meals to consume at home for the weekends. Meals are served ad-libitum, presented in portions that are \> 200% of a regular portion size. Participants are asked to eat from each meal until they feel comfortably full. Food (gram) and energy (kcal) consumed will be recorded at the level of the meal, the day and week of the interventions.
Main study parameters/endpoints: The primary outcome is the between-treatment difference in average (across 14 days) daily energy intake (kcal/day). Secondary study parameters include between-treatment differences in: food intake (g/day), body weight and body composition changes, postprandial hormone responses and respiratory quotient changes to a mixed meal tolerance test, continuous measures of glucose levels, and changes in fasted state leptin and ghrelin levels and blood lipid profiles.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ultra-processed fast eating rate diet then the ultra-processed slow eating rate diet ultra-processed slow eating rate diet Participants assigned to this arm will receive an ultra-processed fast eating rate diet for two weeks, followed by a two week washout period and a two week ultra-processed slow eating rate diet. ultra-processed slow eating rate diet then the ultra-processed fast eating rate diet ultra-processed slow eating rate diet Participants assigned to this arm will receive an ultra-processed slow eating rate diet for two weeks, followed by a two week washout period and a two week ultra-processed fast eating rate diet. ultra-processed slow eating rate diet then the ultra-processed fast eating rate diet Ultra-processed fast eating rate diet Participants assigned to this arm will receive an ultra-processed slow eating rate diet for two weeks, followed by a two week washout period and a two week ultra-processed fast eating rate diet. ultra-processed fast eating rate diet then the ultra-processed slow eating rate diet Ultra-processed fast eating rate diet Participants assigned to this arm will receive an ultra-processed fast eating rate diet for two weeks, followed by a two week washout period and a two week ultra-processed slow eating rate diet.
- Primary Outcome Measures
Name Time Method Average daily energy intake (kcal/day) Two periods of 14 days The average (across two weeks) daily energy intake (kcal/day) in each diet arm
- Secondary Outcome Measures
Name Time Method Cumulative energy intake (kcal) Two periods of 14 days Cumulative energy intake (kcal) over the study period (14 days)
Total Energy intake (kcal) Two periods of 14 days Ad libitum energy intake (kcal) per meal, day and week.
Total Food intake (gram) Two periods of 14 days Ad libitum food intake (gram) per meal, day, week and average daily food intake (gram/day) in each diet arm.
Body weight (kg) Pre and post intervention periods and six times (every other day) during each intervention period of 14 days Participant's weight will be measured in duplicate to obtain an average. The participant will be measured in stocking feet and light clothing on a standard balance scale. Participant will not be able to see their weight.
Postprandial hormone responses (Mixed Meal Tolerance Test) Baseline and post 14-day intervention periods Insulin and glucose, total ghrelin, total GLP-1, PP, PYY, Glucagon and c-peptide responses, to a fixed calorie test meal (rice porridge)
Leptin and Ghrelin levels (Fasted state) Baseline and post 14-day intervention periods Leptin, Ghrelin blood plasma concentrations after an overnight fast
Cumulative food intake (gram) Two periods of 14 days Cumulative food intake (gram) over the study period (14 days)
Total and Regional Fat Mass and Fat Free Mass (kg, %) Pre and post 14-day intervention periods Changes in fat mass and fat free mass (kg, %) will be measured using; DEXA, air displacement plethysmography (BODPOD), skinfold measurements
Metabolic outcomes (Mixed Meal Tolerance Test) Baseline and post 14-day intervention periods Resting energy expenditure will be measured 30 minutes before a Mixed Meal Tolerance Test (MMTT) consisting of a fixed energy amount of rice porridge, and 30 minutes immediately after the meal using a ventilated hood. Based on this we will estimate the respiratory quotient, diet induced thermogenesis and substrate use. Based on the resting energy expenditure in combination with physical activity levels (estimated based on accelerometer (actigraphy) and 24hr recalls of exercise/sports) energy expenditure will be calculated per participant.
Glucose Excursions Every 15 minutes throughout two 14-day intervention periods 24-hour glucose levels will be measured using Continuous Glucose Monitoring (CGM). This will be used for a comparison of percentage of time spent within and out of the normative range.
Blood lipid profile (Fasted state) Baseline and post 14-day intervention periods Total cholesterol, HDL, LDL, free fatty acids and other blood lipids
Trial Locations
- Locations (1)
Wageningen University
🇳🇱Wageningen, Gelderland, Netherlands