Effects of Food Form and Fitness on Appetite and Digestion.
Primary Purpose
High and Increasing Contribution of Energy From Beverages in the Diet May Enhance Positive Energy Balance and Weight Gain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
liquid to liquid
liquid to solid
solid to liquid
solid to solid
Sponsored by
About this trial
This is an interventional basic science trial for High and Increasing Contribution of Energy From Beverages in the Diet May Enhance Positive Energy Balance and Weight Gain focused on measuring obese, liquid, solid, fitness, humans, appetite
Eligibility Criteria
Inclusion Criteria:
- 18-50 years of age BMI of 18-23 kg/m2 (lean) or 30-35 kg/m2 (obese) Sedentary physical activity level (<70th¬ percentile of estimated VO2max for age and sex) or physically Active/Exercisers (>70th¬ percentile of estimated VO2max for age and sex) Good health and not taking any medications known to influence appetite Non-smokers Not pregnant or lactating Weight stable (≤ 3 kg within last 3 months) Dietary restraint score <11 on the Three Factor Eating Questionnaire (included in the on-line screening questionnaire) Glucose Tolerant or Non-Diabetic (fasting blood glucose of <100 mg/dL) Self-reported consumer of breakfast and lunch
Exclusion Criteria:
- History or presence of significant metabolic diseases that may impact study results (i.e., endocrine, hepatic, renal disease) Individuals planning on starting a new diet or exercise regimen during the course of the study Use of obesity pharmacotherapeutic agents or over-the counter anti-obesity agents within the last 3 months Underlying conditions such as any cardiovascular, pulmonary, or neurological dysfunction that may be aggravated with exercise
Sites / Locations
- Purdue University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
liquid to liquid,
liquid to solid,
solid to liquid
solid to solid
Arm Description
Outcomes
Primary Outcome Measures
Change of energy intake.
Effects of actual and perceived food form on short term energy intake in lean and obese, fit and unfit adults.
Secondary Outcome Measures
Change of appetite.
Effects of actual and perceived food form on hunger, fullness, desire to eat, and thirst.
Gastric emptying
Effects of actual and perceived food form on gastric emptying time.
Gastro-intestinal transit
Effects of actual and perceived food form on gastro-intestinal transit time.
Endocrin responses
Effects of actual and perceived food form on GLP-1, CCK, Insulin, Ghrelin concentration.
Glucose response
Effects of actual and perceived food form on serum glucose concentration.
Full Information
NCT ID
NCT01070199
First Posted
February 16, 2010
Last Updated
July 22, 2011
Sponsor
Purdue University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT01070199
Brief Title
Effects of Food Form and Fitness on Appetite and Digestion.
Official Title
Effects of Food Form and Fitness on Appetite and Digestion.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Purdue University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Energy-yielding fluids induce weaker appetitive and compensatory dietary responses than energy-matched semi-solids or solids. This is problematic because the high and increasing contribution of energy from beverages in the diet may enhance positive energy balance and weight gain. The prevailing view of the overweight/obesity problem is that it stems from a small, sustained positive energy balance. It follows then that only small changes, perhaps manipulations in the rheological characteristics of the diet, will be required to correct the problem. Certain populations that are more prone to weight gain may benefit from such manipulations. Obese individuals have a higher beverage intake and experience greater weight loss with reductions in beverage intake. Further, there is evidence that obese individuals consume more energy after a liquid pre-load than their lean counterparts, yet there is no difference in energy intake after a solid load. In contrast, habitual exercisers have been shown to have an increased accuracy of short-term regulation of food intake at meals following liquid preloads. A better understanding of the mechanisms by which beverages and energy-matched solid food forms elicit differential appetitive and dietary responses in these populations needed. This research will attempt to identify the influence of physical fitness and body fat on the ability to compensate for the energy content of solid and liquid preloads by reduction in energy intake at a subsequent ad libitum meal (i.e., acute compensation) and over the course of the day (i.e., short-term compensation). Furthermore, this study will examine the cognitive contribution to differential responses to energy-matched beverage and solid food forms and the effects of mastication on appetite, GI transit, glycemic response, and selected endocrine responses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High and Increasing Contribution of Energy From Beverages in the Diet May Enhance Positive Energy Balance and Weight Gain
Keywords
obese, liquid, solid, fitness, humans, appetite
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
liquid to liquid,
Arm Type
Experimental
Arm Title
liquid to solid,
Arm Type
Experimental
Arm Title
solid to liquid
Arm Type
Experimental
Arm Title
solid to solid
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
liquid to liquid
Other Intervention Name(s)
Liquid test load
Intervention Description
• One test session will involve presentation of a glass of clear cherry-flavored unthickened beverage (Kool-Aid, Kraft Foods Inc., White Plains, NY). This session will be referred to as the "Liquid to Liquid" session as the participants will be consuming a liquid and be told that the consistency in their stomach will be a liquid.
Intervention Type
Behavioral
Intervention Name(s)
liquid to solid
Other Intervention Name(s)
liquid test load
Intervention Description
This session involves a solution of calcium chloride and a solution of sodium alginate. The participant will be instructed to pour the cherry-flavored beverage/alginate solution into the calcium chloride. The result is a solid mass. They are allowed to examine the solution to confirm the solid texture and consistency.Participants will be told that this same reaction will occur in their stomach when the session's beverage is consumed due to the effect of gastric acid on the solution. But, the participant will be consuming the same cherry-flavored beverage as in the 1st session. Thus, they will believe that their GI tract will be challenged with a solid mass, but in reality, the challenge is the same (i.e., liquid).Therefore, the only difference between the test sessions is expectation.
Intervention Type
Behavioral
Intervention Name(s)
solid to liquid
Other Intervention Name(s)
liquid test load
Intervention Description
• This session will involve the same dense gelatin cubes previously described, but participants will be told that the solid cubes will turn to liquid when they come into contact with the acid in their stomach. This trial will be known as "Solid to Liquid". A demonstration of the "Solid to Solid" and "Solid to Liquid" phases will be shown to the participant before they consume the load. Both phases exhibited by placing two cubes into separate containers filled with similar looking clear liquids. The "Solid to Solid" phase container will contain cold water so the cube stays in solid form. The "Solid to Liquid" phase container will contain hot water that will quickly dissolve the cube into a liquid form.
Intervention Type
Behavioral
Intervention Name(s)
solid to solid
Other Intervention Name(s)
liquid test load
Intervention Description
Participants will be presented with dense gelatin cubes. These 1" x 1" x 1" cubes will have a solid appearance and require mastication, but is isocaloric to the beverage. However, after mastication and gastric processing, the solid rapidly breaks down into a clear fluid.However, participants will be informed that the cubes will remain the same solid consistency in their stomach. The masticatory process and stimulus form will be standardized through the use of a metronome. Participants will be required to chew the solid cube at a fixed rate prior to swallowing. Thus, adding to the cognitive impression that they are eating a solid when essentially the GI challenge will be similar to the beverage.
Primary Outcome Measure Information:
Title
Change of energy intake.
Description
Effects of actual and perceived food form on short term energy intake in lean and obese, fit and unfit adults.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Change of appetite.
Description
Effects of actual and perceived food form on hunger, fullness, desire to eat, and thirst.
Time Frame
4 hours
Title
Gastric emptying
Description
Effects of actual and perceived food form on gastric emptying time.
Time Frame
4 hours
Title
Gastro-intestinal transit
Description
Effects of actual and perceived food form on gastro-intestinal transit time.
Time Frame
4 hours
Title
Endocrin responses
Description
Effects of actual and perceived food form on GLP-1, CCK, Insulin, Ghrelin concentration.
Time Frame
4 hours
Title
Glucose response
Description
Effects of actual and perceived food form on serum glucose concentration.
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-50 years of age BMI of 18-23 kg/m2 (lean) or 30-35 kg/m2 (obese) Sedentary physical activity level (<70th¬ percentile of estimated VO2max for age and sex) or physically Active/Exercisers (>70th¬ percentile of estimated VO2max for age and sex) Good health and not taking any medications known to influence appetite Non-smokers Not pregnant or lactating Weight stable (≤ 3 kg within last 3 months) Dietary restraint score <11 on the Three Factor Eating Questionnaire (included in the on-line screening questionnaire) Glucose Tolerant or Non-Diabetic (fasting blood glucose of <100 mg/dL) Self-reported consumer of breakfast and lunch
Exclusion Criteria:
History or presence of significant metabolic diseases that may impact study results (i.e., endocrine, hepatic, renal disease) Individuals planning on starting a new diet or exercise regimen during the course of the study Use of obesity pharmacotherapeutic agents or over-the counter anti-obesity agents within the last 3 months Underlying conditions such as any cardiovascular, pulmonary, or neurological dysfunction that may be aggravated with exercise
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22258267
Citation
Cassady BA, Considine RV, Mattes RD. Beverage consumption, appetite, and energy intake: what did you expect? Am J Clin Nutr. 2012 Mar;95(3):587-93. doi: 10.3945/ajcn.111.025437. Epub 2012 Jan 18.
Results Reference
derived
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Effects of Food Form and Fitness on Appetite and Digestion.
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