- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01070199
Effects of Food Form and Fitness on Appetite and Digestion.
July 22, 2011 updated by: Purdue University
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: liquid 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.
Other Names:
|
Experimental: liquid 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.
Other Names:
|
Experimental: solid 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.
Other Names:
|
Experimental: solid 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of energy intake.
Time Frame: 24 hours
|
Effects of actual and perceived food form on short term energy intake in lean and obese, fit and unfit adults.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of appetite.
Time Frame: 4 hours
|
Effects of actual and perceived food form on hunger, fullness, desire to eat, and thirst.
|
4 hours
|
Gastric emptying
Time Frame: 4 hours
|
Effects of actual and perceived food form on gastric emptying time.
|
4 hours
|
Gastro-intestinal transit
Time Frame: 4 hours
|
Effects of actual and perceived food form on gastro-intestinal transit time.
|
4 hours
|
Endocrin responses
Time Frame: 4 hours
|
Effects of actual and perceived food form on GLP-1, CCK, Insulin, Ghrelin concentration.
|
4 hours
|
Glucose response
Time Frame: 4 hours
|
Effects of actual and perceived food form on serum glucose concentration.
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
February 16, 2010
First Submitted That Met QC Criteria
February 16, 2010
First Posted (Estimate)
February 17, 2010
Study Record Updates
Last Update Posted (Estimate)
July 25, 2011
Last Update Submitted That Met QC Criteria
July 22, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DK079913 (U.S. NIH Grant/Contract)
- 0805006922 (Other Identifier: Purdue University)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on liquid to liquid
-
American University of Beirut Medical CenterNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)RecruitingNicotine Dependence | Nicotine Vaping | Nicotine AddictionLebanon
-
Boston Children's HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingDysphagia | Aspiration | Brief Resolved Unexplained Event (BRUE) | Apparent Life Threatening Event (ALTE)United States
-
Dana-Farber Cancer InstituteHarvard University; Conquer Cancer Foundation; Alex's Lemonade Stand Foundation; Sam Day FoundationRecruitingEwing Sarcoma of Bone | Ewing Sarcoma | Peripheral Primitive Neuroectodermal Tumor | Peripheral Primitive Neuroectodermal Tumor of Bone | High-grade Osteosarcoma | Ewing Sarcoma of Soft Tissue | Peripheral Primitive Neuroectodermal Tumor of Soft TissueUnited States
-
Abbott NutritionNot yet recruiting
-
Columbia UniversityCompletedBladder Cancer | ComplicationsUnited States
-
Clinical Nutrition Research Centre, SingaporeDanone ResearchCompletedDiabetes | Impaired Glucose TolerenceSingapore
-
Icahn School of Medicine at Mount SinaiCompletedGrowth in Premature InfantsUnited States
-
Imperial College LondonRecruitingObesity | Eating Behavior | Appetitive BehaviorUnited Kingdom
-
Yale UniversityNational Institute on Drug Abuse (NIDA)Not yet recruiting
-
University Hospital, Strasbourg, FranceRecruitingElectronic CigaretteFrance