Effects of Food Form on Cephalic Phase Responses

Purdue University

Status: Completed

Conditions: Overweight; Obese

Treatments: Behavioral: Not Learned: Nutritive beverage to Non-nutritive beverage; Behavioral: Learned: Non-nutritive beverage to Non-nutritive beverage; Behavioral: Not Learned: Non-Nutritive solid to Non-nutritive solid; Behavioral: Learned: Nutritive beverage to Nutritive beverage; Behavioral: Not Learned: Non-nutritive beverage to Nutritive beverage; Behavioral: Learned: Nutritive solid to Nutritive solid; Behavioral: Not Learned: Non-nutritive solid to Nutritive solid; Behavioral: Not Learned: Non-Nutritive solid to Non-Nutritive Solid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01550133

R01DK079913-4

R01DK079913 (U.S. NIH Grant/Contract)

1201011780 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 8 patient groups

Not Learned: Non-nutritive bev to Nutritive bev

Experimental group

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.

Treatment:

Behavioral: Learned: Non-nutritive beverage to Non-nutritive beverage

Not Learned: Nutritive solid to Non-Nutritive solid

Experimental group

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 non-nutritive solid and act as a control for the learned effects.

Treatment:

Behavioral: Learned: Nutritive solid to Nutritive solid

Not Learned: Nutritive beverage to Non-Nutritive beverage

Experimental group

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 non-nutritive beverage and act as a control for the learned effects.

Treatment:

Behavioral: Learned: Nutritive beverage to Nutritive beverage

Learned: Non-Nutritive solid to Non-Nutritive solid

Experimental group

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.

Treatment:

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

Learned: Non-Nutritive beverage to Non-Nutritive beverage

Experimental group

Description:

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.

Treatment:

Behavioral: Not Learned: Nutritive beverage to Non-nutritive beverage

Learned: Nutritive solid to Nutritive solid

Experimental group

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.

Treatment:

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

Learned: Nutritive beverage to Nutritive beverage

Experimental group

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.

Treatment:

Behavioral: Not Learned: Non-nutritive beverage to Nutritive beverage

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

Experimental group

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.

Treatment:

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