Clinical trial NCT04484974: Effects of Pecan Nut Snacks v Equicaloric Snacks on Appetite, Food Intake, Metabolism, Hormones and Biomarkers
Official title: A Randomized, Two Condition, Crossover Trial Assessing Appetite, Energy Metabolism, Blood Biomarker and ad Libitum Food Intake Responses to a Mid-morning Pecan Snack vs. an Equicaloric High Carbohydrate Savory Snack in Healthy Volunteers With Overweight/Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Pecans
appetite
hormones
food intake
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American Pecan Council
First posted: 2020-07-24
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, two period crossover with two treatment conditions
Primary purpose: BASIC_SCIENCE

Brief summary: This is a within-subjects crossover study that examines subjective appetite, food intake, hormone and metabolic responses to consumption of mid morning snacks of pecan nuts as compared to an iso-caloric amount of tortilla chips. Pecans are high in fat and calories and low in carbohydrate by weight, while tortilla chips are mostly carbohydrate and essentially devoid of fat. These two very different nutrient profiles should elicit different metabolic and biomarker responses. The study aims to determine whether these treatments also elicit different subjective appetite and food intake responses. Participants will be healthy volunteers with overweight and obesity, a population that may be seeking healthy snacking options that are satisfying and satiating.

Detailed description: This is a randomized, two condition, crossover study in healthy individuals with overweight and obesity examining the effect of a mid-morning snack of pecans vs. a low fat savory snack on appetite, energy expenditure, blood biomarkers of appetite and metabolism and ad libitum food intake at lunch. Twenty-four participants will be enrolled and studied on two test days with at least one week washout in between. On test days, participants will have baseline measures of appetite (by Visual Analogue Scale (VAS)), blood hormones and substrates, and energy expenditure and fuel oxidation (Resting Metabolic Rate (RMR), by indirect calorimetry) taken just prior to consuming a standardized 300 kcal breakfast. VAS measures will be taken at 20, 30, 60, 90 and 120 min following the meal and RMR will be measured for 20 min after eating. A mid-morning snack of either 250 kcal of pecans or lightly salted tortilla chips will be consumed and VAS and blood measures will be taken at 20, 30, 60, 90 and 120 min following the snack and RMR will be measured for 20 min after eating. Participants will be given an ad libitum lunch meal and VAS and blood measures will be taken at 20, 30, 60, 90 and 120 min following the lunch and RMR will be measured for 20 min after eating. Blood will be analyzed for glucose, insulin, free fatty acids, triglycerides, ghrelin, leptin, PYY, and GLP-1. Two hypotheses will be examined: 1. pecans will provoke greater feelings of fullness and reduced hunger after the snack and lunch meal consumption (on either a calorie per calorie or volume basis) as compared to the tortilla chip snack, and 2. the pecan snack will provoke greater responses of satiety hormones compared to tortilla chips. Post-snack and lunch energy expenditure and fat oxidation will also be compared between treatments as an exploratory aim.

Eligibility criteria: Inclusion Criteria:

1. 35 adult men and women
2. all ethnic groups
3. ages 20-50,
4. BMI 27-35,
5. habitually eat breakfast,
6. willing to eat the test snacks and other foods offered,
7. weight stable for the last 6 months
8. willing to consent and adhere to the test procedures and schedule

Exclusion Criteria:

1. nut allergies,
2. uncontrolled thyroid disorders,
3. diabetes mellitus,
4. eating disorders,
5. pregnant, or planning to become pregnant during the study,
6. lactating,
7. uncontrolled hypertension,
8. active dieting
9. intensive physical activity training regimen (\>300 min/wk exercise),
10. medical history or current medication that may affect study outcomes per study PI discretion
11. consuming pecans on a regular basis
12. unable to lie still with a clear hood over their head for the measurement of energy expenditure

Primary outcomes:
measure: Change from baseline (before snack consumption) to 120 minutes in subjective appetite response to pecan or pretzel snack using visual analog assessment
timeFrame: Baseline (prior to mid-morning snack consumption) to 120 minutes after snack consumption at 20, 30, 60, 90 and 120 minutes following consumption.
measure: Change from baseline (prior to lunch) to 120 minutes in subjective appetite response to lunch meal using visual analog assessment
timeFrame: Prior to lunch consumption and at 20, 30, 60, 90 and 120 minutes following consumption.
measure: Energy intake response to pecan or pretzel snack using weighed food intake measures
timeFrame: 30 minutes allowed for completion of the lunch meal
measure: Change from baseline (prior to snack consumption) to 120 minutes in serum glucose following pecan or pretzel snack consumption.
timeFrame: Baseline (prior to snack) to 120 minutes at intervals of 20, 30, 60, 90 and 120 minutes.
measure: Change from baseline (prior to lunch consumption) to 120 minutes in serum glucose following lunch consumption.
timeFrame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
measure: Change from baseline (prior to snack consumption) to 120 minutes in serum insulin following pecan or pretzel snack consumption.
timeFrame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
measure: Change from baseline (prior to lunch consumption) to 120 minutes in serum insulin following lunch consumption.
timeFrame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
measure: Change from baseline (prior to snack consumption) to 120 minutes in serum triglycerides following pecan or pretzel snack consumption.
timeFrame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
measure: Change from baseline (prior to lunch consumption) to 120 minutes in serum triglycerides following lunch consumption.
timeFrame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
measure: Change from baseline (prior to snack consumption) to 120 minutes in serum free fatty acids following snack consumption.
timeFrame: Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
measure: Change from baseline (prior to lunch consumption) to 120 minutes in serum free fatty acids following lunch consumption.
timeFrame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
measure: Change from baseline (prior to snack consumption) to 120 minutes in serum ghrelin following snack consumption.
timeFrame: Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
measure: Change from baseline (prior to lunch consumption) to 120 minutes in serum ghrelin following lunch consumption.
timeFrame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
measure: Change from baseline (prior to snack consumption) to 120 minutes in serum peptide YY following snack consumption.
timeFrame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
measure: Change from baseline (prior to lunch consumption) to 120 minutes in serum peptide YY following lunch consumption.
timeFrame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
measure: Change from baseline (prior to snack consumption) to 120 minutes in serum glucagon like peptide-1 following snack consumption.
timeFrame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
measure: Change from baseline (prior to lunch consumption) to 120 minutes in serum glucagon like peptide-1 following lunch consumption.
timeFrame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
measure: Change in serum leptin from baseline to 120 minutes following snack consumption
timeFrame: Baseline (prior to breakfast) and at 120 minutes following mid-morning snack consumption.
Secondary outcomes:
measure: Change from baseline in energy expenditure post snack
timeFrame: Resting energy expenditure will be measured for 20 minutes after snack consumption.
measure: Change from baseline in energy expenditure post lunch
timeFrame: Resting energy expenditure will be measured for 20 minutes after lunch consumption.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Health and Wellness Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: John C Peters, PhD
role: PRINCIPAL_INVESTIGATOR
References: