Effects of Food Form on Cephalic Phase Responses
Effects of Nutritive and Non-Nutritive Food Form and Learning on Cephalic Phase Responses
3 other identifiers
interventional
60
1 country
1
Brief Summary
This study has two main aims: 1) To determine if ingestion of solid or beverage food forms will change appetite hormone responses, and 2) To determine whether "learning" (defined as 2 week daily consumption) about the metabolic consequence of ingesting solid or beverage foods forms varying in energy alters appetite hormone responses. Beverage consumption has been implicated in the problem of obesity. However, the exact relationship between beverages, lower appetitive response and lower compensatory dietary responses remains unclear. This study aims to address this gap in the research. For aim 1, the null hypothesis is that the energy in beverage and solid forms will not affect appetite hormonal responses differently. The alternative hypothesis is that exposure to the energy-yielding beverage will elicit a lower appetitive hormone response compared to oral exposure to the solid food form. For aim 2, the null hypothesis is that learning will not change appetite hormone responses. The alternative hypothesis is that learning will decrease appetite hormone responses in the non-energy-yielding beverage more than in the energy-yielding beverage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2012
CompletedFirst Posted
Study publicly available on registry
March 9, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2016
CompletedDecember 12, 2023
December 1, 2023
3.7 years
March 7, 2012
December 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Appetite Hormone Response
Determine the appetite hormone responses to oral exposure of nutritive (energy-yielding) or non-nutritive (non-energy-yielding) sweetener in beverage or solid form. Then, determine whether the appetite hormone responses change after a 2-week learning period. Appetite hormones to be measured: Cholecystokinin, Glucagon-Like-Peptide-1, Ghrelin, Insulin, Pancreatic Polypeptide
week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week over 136 minutes: 0, 14, 16, 18, 20, 22, 24, 26, 28, 30, 76, 106, 136 minutes)
Secondary Outcomes (3)
Change in Appetite
week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week, over 180 minutes: 0, 14, 30, 76, 106, 136, 180 minutes)
Plasma Glucose
week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week, over 136 minutes: 0, 14, 16, 18, 20, 22, 24, 26, 28, 30, 76, 106, 136 minutes)
Amount of meal ingested
week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week, at 137 minutes to 180 minutes)
Study Arms (8)
Not Learned: Non-nutritive bev to Nutritive bev
EXPERIMENTAL15 participants will be randomly assigned to eat 250 grams of non-nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a nutritive solid and act as a control for the learned effects.
Not Learned: Nutritive solid to Non-Nutritive solid
EXPERIMENTAL15 participants will be randomly assigned to eat 250 grams of nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive solid and act as a control for the learned effects.
Not Learned: Nutritive beverage to Non-Nutritive beverage
EXPERIMENTAL15 participants will be randomly assigned to drink 400 grams of nutritive beverage consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive beverage and act as a control for the learned effects.
Learned: Non-Nutritive solid to Non-Nutritive solid
EXPERIMENTAL15 participants will be randomly assigned to eat 250 grams of non-nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive solid to determine if cephalic phase response changes with learning.
Learned: Non-Nutritive beverage to Non-Nutritive beverage
EXPERIMENTAL15 participants will be randomly assigned to drink 400 grams of non-nutritive beverage consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive beverage to determine if cephalic phase response changes with learning.
Learned: Nutritive solid to Nutritive solid
EXPERIMENTAL15 participants will be randomly assigned to eat 250 grams of nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a nutritive solid to determine if cephalic phase response changes with learning.
Learned: Nutritive beverage to Nutritive beverage
EXPERIMENTAL15 participants will be randomly assigned to drink 400 grams of nutritive beverage consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a nutritive beverage to determine if cephalic phase response changes with learning.
Not Learned: Non-Nutritive solid to Non-Nutritive solid
EXPERIMENTAL15 participants will be randomly assigned to eat 250 grams of non-nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive solid to determine if cephalic phase response changes with learning.
Interventions
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage product made with non-nutritive sweetener everyday for two weeks.Half of these participants will then be tested against a non-nutritive beverage.
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive solid.
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive beverage.
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with non-nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive solid.
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage food product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a non-nutritive beverage.
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a non-nutritive solid.
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage food product made with non-nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive beverage.
Eligibility Criteria
You may qualify if:
- Body fat percentage \> 25% for men and \> 32% for women. BMI of 24 kg/m2- 37kg/m2
- No purposeful use of foods or beverages that are sweetened with non-nutritive sweetener \> 3 times a week
- No purposeful addition of non-nutritive sweetener to foods and beverages \>3 times a week
- No Phenylketonuria (PKU)
- Rate palatability of test load and food sample as greater than 5 on a 9 point category scale.
- Be willing to eat at least 100 grams of carbohydrates for three days prior to each test day
- Self-reported consumer of breakfast and lunch
- Be willing to eat macaroni and cheese during breakfast-lunch hours
- Not taking medications known to influence appetite
- Non-smoker \>1 year or more
- Habitual activity pattern over the last 3 months and no plan to change this over the course of the study
- Not on any extreme diet (e.g. Atkins Diet)
- Weight stable (≤ 5 kg change over the last 3 months)
- Not a restrained eater (have a dietary restraint score of \<9 on the Three Factor Eating Questionnaire-Restraint section)
- Not a disordered eater (Have a score of \<20 in the Eating Attitudes Test-26)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Purdue University
West Lafayette, Indiana, 47907, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor
Study Record Dates
First Submitted
March 7, 2012
First Posted
March 9, 2012
Study Start
September 1, 2012
Primary Completion
April 30, 2016
Study Completion
December 30, 2016
Last Updated
December 12, 2023
Record last verified: 2023-12