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Effects of Food Form and Fitness on Appetite and Digestion.

22. juli 2011 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

81

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Indiana
      • West Lafayette, Indiana, Forente stater, 47907
        • Purdue University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 50 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Andre navn:
  • Liquid test load
Eksperimentell: 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.
Andre navn:
  • liquid test load
Eksperimentell: 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.
Andre navn:
  • liquid test load
Eksperimentell: 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.
Andre navn:
  • liquid test load

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change of energy intake.
Tidsramme: 24 hours
Effects of actual and perceived food form on short term energy intake in lean and obese, fit and unfit adults.
24 hours

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change of appetite.
Tidsramme: 4 hours
Effects of actual and perceived food form on hunger, fullness, desire to eat, and thirst.
4 hours
Gastric emptying
Tidsramme: 4 hours
Effects of actual and perceived food form on gastric emptying time.
4 hours
Gastro-intestinal transit
Tidsramme: 4 hours
Effects of actual and perceived food form on gastro-intestinal transit time.
4 hours
Endocrin responses
Tidsramme: 4 hours
Effects of actual and perceived food form on GLP-1, CCK, Insulin, Ghrelin concentration.
4 hours
Glucose response
Tidsramme: 4 hours
Effects of actual and perceived food form on serum glucose concentration.
4 hours

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2009

Primær fullføring (Faktiske)

1. desember 2009

Studiet fullført (Faktiske)

1. desember 2010

Datoer for studieregistrering

Først innsendt

16. februar 2010

Først innsendt som oppfylte QC-kriteriene

16. februar 2010

Først lagt ut (Anslag)

17. februar 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

25. juli 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. juli 2011

Sist bekreftet

1. juli 2011

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R01DK079913 (U.S. NIH-stipend/kontrakt)
  • 0805006922 (Annen identifikator: Purdue University)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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