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Completed

NCT Number: NCT01550133

Effects of Food Form on Cephalic Phase Responses

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.

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Key information

Conditions

Obese Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Learned: Non-nutritive beverage to Non-nutritive beverage

Behavioral

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 names: NNB to NNB

Learned: Nutritive solid to Nutritive solid

Behavioral

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 names: NS to NS

Learned: Nutritive beverage to Nutritive beverage

Behavioral

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 names: NB to NB

Not Learned: Non-nutritive solid to Nutritive solid

Behavioral

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 names: NNS to NS

Not Learned: Nutritive beverage to Non-nutritive beverage

Behavioral

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 names: NB to NNB

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

Behavioral

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 names: NS to NNS

Not Learned: Non-nutritive beverage to Nutritive beverage

Behavioral

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 names: NNB to NB

Primary outcomes

  1. 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)

    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 outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. 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)

    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.

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 9, 2012
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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