Effects of Food Form on Cephalic Phase Responses

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Purdue University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Richard Mattes, Purdue University
ClinicalTrials.gov Identifier:
NCT01550133
First received: March 7, 2012
Last updated: November 21, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention
Obese
Overweight
Behavioral: Learned: Non-nutritive beverage to Non-nutritive beverage
Behavioral: Learned: Nutritive solid to Nutritive solid
Behavioral: Learned: Nutritive beverage to Nutritive beverage
Behavioral: Not Learned: Non-nutritive solid to Nutritive solid
Behavioral: Not Learned: Nutritive beverage to Non-nutritive beverage
Behavioral: Not Learned: Non-Nutritive solid to Non-nutritive solid
Behavioral: Not Learned: Non-nutritive beverage to Nutritive beverage
Behavioral: Not Learned: Non-Nutritive solid to Non-Nutritive Solid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effects of Nutritive and Non-Nutritive Food Form and Learning on Cephalic Phase Responses

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Appetite Hormone Response [ Time Frame: 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) ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Change in Appetite [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Determining changes in appetite ratings with oral exposure to nutritive or non-nutritive sweetener in beverage or solid food form and lastly with a meal.

  • Plasma Glucose [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Determine the differences in plasma glucose concentration after oral exposure to nutritive or non-nutritive sweetener in beverage or solid food forms and whether there are changes after a 2-week learning period.

  • Amount of meal ingested [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Amount of meal ingested will be determined by presenting a pre-weighted meal and water to the participant at 137 minutes. The meal will be provided in excess of an amount that can be consumed. Participants are asked to eat until comfortably full. The amount ingested will be determined by covertly re-weighing the amount remaining.


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Not Learned: Non-nutritive bev to Nutritive bev
15 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.
Behavioral: Learned: Non-nutritive beverage to Non-nutritive beverage
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.
Other Name: NNB to NNB
Experimental: Not Learned: Nutritive solid to Non-Nutritive solid
15 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.
Behavioral: Learned: Nutritive solid to Nutritive solid
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.
Other Name: NS to NS
Experimental: Not Learned: Nutritive beverage to Non-Nutritive beverage
15 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.
Behavioral: Learned: Nutritive beverage to Nutritive beverage
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.
Other Name: NB to NB
Experimental: Learned: Non-Nutritive solid to Non-Nutritive solid
15 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.
Behavioral: Not Learned: Non-nutritive solid to Nutritive solid
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.
Other Name: NNS to NS
Experimental: Learned: Non-Nutritive beverage to Non-Nutritive beverage
15 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.
Behavioral: Not Learned: Nutritive beverage to Non-nutritive beverage
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.
Other Name: NB to NNB
Experimental: Learned: Nutritive solid to Nutritive solid
15 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.
Behavioral: Not Learned: Non-Nutritive solid to Non-nutritive solid
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.
Other Name: NS to NNS
Experimental: Learned: Nutritive beverage to Nutritive beverage
15 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.
Behavioral: Not Learned: Non-nutritive beverage to Nutritive beverage
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.
Other Name: NNB to NB
Experimental: Not Learned: Non-Nutritive solid to Non-Nutritive solid
15 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.
Behavioral: Not Learned: Non-Nutritive solid to Non-Nutritive Solid
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 non-nutritive solid.
Other Name: NNS to NNS

Detailed Description:

The main aims will be studied in 3 phases. In phase 1,the unconditioned cephalic phase responses of participants to nutritive and non-nutritive beverage and solid food forms will be determined. In phase 2, participants will consume a randomly allocated solid food or beverage (either nutritive or non-nutritive) consecutively for 2 weeks. In phase 3, (which will occur immediately after the end of Phase 2), participants will be retested for their cephalic phase responses to determine if there is an effect of learning on appetite hormone response.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)
  • Have not donated blood for at least 3 months prior to participating in the study
  • Indicate no plan to donate blood during, and for three months after the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550133

Contacts
Contact: Janice Y Lee, B.S. 765-494-3607 jyxlee@purdue.edu
Contact: Richard D Mattes, MPH, Ph.D. 765-494-0662 mattes@purdue.edu

Locations
United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Richard D Mattes, MPH, Ph.D.    765-494-0662      
Principal Investigator: Richard D Mattes, MPH, Ph.D.         
Sponsors and Collaborators
Purdue University
  More Information

No publications provided

Responsible Party: Richard Mattes, Distinguished Professor, Purdue University
ClinicalTrials.gov Identifier: NCT01550133     History of Changes
Other Study ID Numbers: R01DK079913-4, R01DK079913, 1201011780
Study First Received: March 7, 2012
Last Updated: November 21, 2013
Health Authority: United States: Federal Government

Keywords provided by Purdue University:
Peptides
Hormones
Appetite
Humans
Obese
Beverage
Solid food
cephalic phase

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014