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Effects of Food Form on Cephalic Phase Responses

Primary Purpose

Obese, Overweight

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Learned: Non-nutritive beverage to Non-nutritive beverage

Learned: Nutritive solid to Nutritive solid

Learned: Nutritive beverage to Nutritive beverage

Not Learned: Non-nutritive solid to Nutritive solid

Not Learned: Nutritive beverage to Non-nutritive beverage

Not Learned: Non-Nutritive solid to Non-nutritive solid

Not Learned: Non-nutritive beverage to Nutritive beverage

Not Learned: Non-Nutritive solid to Non-Nutritive Solid

About this trial

This is an interventional basic science trial for Obese focused on measuring Peptides, Hormones, Appetite, Humans, Obese, Beverage, Solid food, cephalic phase

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Purdue University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Not Learned: Non-nutritive bev to Nutritive bev

Not Learned: Nutritive solid to Non-Nutritive solid

Not Learned: Nutritive beverage to Non-Nutritive beverage

Learned: Non-Nutritive solid to Non-Nutritive solid

Learned: Non-Nutritive beverage to Non-Nutritive beverage

Learned: Nutritive solid to Nutritive solid

Learned: Nutritive beverage to Nutritive beverage

Not Learned: Non-Nutritive solid to Non-Nutritive solid

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Appetite

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

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

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.

Full Information

NCT ID

NCT01550133

First Posted

March 7, 2012

Last Updated

October 4, 2016

Sponsor

Purdue University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT01550133

Brief Title

Effects of Food Form on Cephalic Phase Responses

Official Title

Effects of Nutritive and Non-Nutritive Food Form and Learning on Cephalic Phase Responses

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Purdue University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obese, Overweight

Keywords

Peptides, Hormones, Appetite, Humans, Obese, Beverage, Solid food, cephalic phase

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Not Learned: Non-nutritive bev to Nutritive bev

Arm Type

Experimental

Arm Description

Arm Title

Not Learned: Nutritive solid to Non-Nutritive solid

Arm Type

Experimental

Arm Description

Arm Title

Not Learned: Nutritive beverage to Non-Nutritive beverage

Arm Type

Experimental

Arm Description

Arm Title

Learned: Non-Nutritive solid to Non-Nutritive solid

Arm Type

Experimental

Arm Description

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.

Arm Title

Learned: Non-Nutritive beverage to Non-Nutritive beverage

Arm Type

Experimental

Arm Description

Arm Title

Learned: Nutritive solid to Nutritive solid

Arm Type

Experimental

Arm Description

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.

Arm Title

Learned: Nutritive beverage to Nutritive beverage

Arm Type

Experimental

Arm Description

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.

Arm Title

Not Learned: Non-Nutritive solid to Non-Nutritive solid

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Learned: Non-nutritive beverage to Non-nutritive beverage

Other Intervention Name(s)

NNB to NNB

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Learned: Nutritive solid to Nutritive solid

Other Intervention Name(s)

NS to NS

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Learned: Nutritive beverage to Nutritive beverage

Other Intervention Name(s)

NB to NB

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Not Learned: Non-nutritive solid to Nutritive solid

Other Intervention Name(s)

NNS to NS

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Not Learned: Nutritive beverage to Non-nutritive beverage

Other Intervention Name(s)

NB to NNB

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Not Learned: Non-Nutritive solid to Non-nutritive solid

Other Intervention Name(s)

NS to NNS

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Not Learned: Non-nutritive beverage to Nutritive beverage

Other Intervention Name(s)

NNB to NB

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Not Learned: Non-Nutritive solid to Non-Nutritive Solid

Other Intervention Name(s)

NNS to NNS

Intervention Description

Primary Outcome Measure Information:

Title

Appetite Hormone Response

Description

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)

Secondary Outcome Measure Information:

Title

Change in Appetite

Description

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.

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)

Title

Plasma Glucose

Description

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)

Title

Amount of meal ingested

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Purdue University

City

West Lafayette

State/Province

Indiana

ZIP/Postal Code

47907

Country

United States

12. IPD Sharing Statement

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Effects of Food Form on Cephalic Phase Responses

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