CClinicalTrials.gg
CompletedNCT01070199Updated Jul 25, 2011

Effects of Food Form and Fitness on Appetite and Digestion.

An interventional study of liquid to liquid and liquid to solid in High and Increasing Contribution of Energy From Beverages in the Diet May Enhance Positive Energy Balance and Weight Gain, sponsored by Purdue University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-25.

Sponsored by Purdue University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • High and Increasing Contribution of Energy From Beverages in the Diet May Enhance Positive Energy Balance and Weight Gain

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Keywords

  • obese, liquid, solid, fitness, humans, appetite
03

In context

Weight Gain

405 studies on the registry are indexed under Weight Gain; 52 are open to participants now.

This study's enrollment of 81 is close to the median of 83 across 324 interventional studies indexed under Weight Gain.

Browse Weight Gain studies →

Lead sponsor

Purdue University is the lead sponsor of 168 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    liquid to liquid,

    Behavioral: liquid to liquid

  • Experimental
    liquid to solid,

    Behavioral: liquid to solid

  • Experimental
    solid to liquid

    Behavioral: solid to liquid

  • Experimental
    solid to solid

    Behavioral: solid to solid

Interventions

  • Behavioralliquid to liquid

    • 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.

    Also known as: Liquid test load

  • Behavioralliquid to solid

    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.

    Also known as: liquid test load

  • Behavioralsolid to liquid

    • 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.

    Also known as: liquid test load

  • Behavioralsolid to solid

    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.

    Also known as: liquid test load

06

What researchers measure

Primary outcomes

  1. Change of energy intake.

    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 outcomes

  1. Change of appetite.

    Effects of actual and perceived food form on hunger, fullness, desire to eat, and thirst.

    Time frame: 4 hours

  2. Gastric emptying

    Effects of actual and perceived food form on gastric emptying time.

    Time frame: 4 hours

  3. Gastro-intestinal transit

    Effects of actual and perceived food form on gastro-intestinal transit time.

    Time frame: 4 hours

  4. Endocrin responses

    Effects of actual and perceived food form on GLP-1, CCK, Insulin, Ghrelin concentration.

    Time frame: 4 hours

  5. Glucose response

    Effects of actual and perceived food form on serum glucose concentration.

    Time frame: 4 hours

07

Study locations

1 site
  • Purdue University
    West Lafayette, Indiana 47907, United States
08

References and documents

Publications

  • 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. PubMed 22258267 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01070199
Lead sponsor
Purdue University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted
Feb 17, 2010
Start date
Jan 2009
Primary completion
Dec 2009
Completion
Dec 2010
Last update
Jul 25, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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