- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02052076
Influence of the Constancy of Daily Meal Pattern on Energy Balance, Glucose Profiles an Appetite in Healthy Women
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Background:
Previous work in our laboratory has shown that there are potentially important negative health consequences associated with irregular eating. Greater fasting levels of total-cholesterol and LDL-cholesterol, a decrease in meal induced thermogenesis, and as a greater insulin response to a test drink, were observed in healthy women following a two-week period of irregular meal pattern (variable number of daily meals; from 3 to 9); this was in contrast to a regular pattern of six daily meals. In addition a greater energy intake was self-reported during irregular compared with the regular meal pattern. Subsequent studies have confirmed such an effect in overweight subjects and also provided evidence of alterations in subjective appetite which may influence ad-libitum food intake. The present project will study normal weight subjects, and incorporate energy expenditure measurement under free living conditions using a novel technique (SenseWear armband, SWA), continuous glucose monitor, and obtain more detailed information about appetite and food intake.
Aims:
To investigate the effects of regular and irregular meal pattern on energy expenditure, energy intake, , Glucose profiles and subjective appetite in healthy normal weight women.
Experimental protocol and methods:
Normal weight women (BMI 18.5-25) who are otherwise healthy will be studied during the early phase of their menstrual cycle (first week).
Subjects will be initially screened and then complete a 7 days food diary before participating in the study which will last for a total of 6 weeks. During the first 2 weeks participants will adopt one of two meal patterns, followed by a two-week washout period on habitual diet and meal pattern, before undertaking a second 2-week intervention following the second meal pattern. The meal patterns will be 1) regular - 6 daily meals or snacks for 2 weeks, or 2) irregular - a different number (between 3 and 9) of meals/snacks every day. All foods to be consumed during weeks1, 2, 5 and 6 will be provided free of charge, and will comprise foods commonly consumed in the British diet in amounts designed to keep body weight constant during the study. Participants will complete food diaries over the study period. Subjects will wear a SenseWare device (attached to an upper arm) to allow physical activity and energy expenditure to be estimated in weeks1, 2, 5 and 6. Subjects will attend the lab on the 6th day of each intervention phase to have a continuous glucose monitoring probe inserted in their subcutaneous tissue over the abdomen and attached to a small monitor. Subjects will also need to measure their blood glucose four times a day using a fingerprick to obtain a droplet of blood and analysing it with a pocket glucose analyser. After three seven subjects will be asked to come back to have the device removed.
Subjective appetite (hunger, fullness, etc.) will be assessed using visual analogue scales (VAS) during the intervention (at the end of the first and second week) Before and after each intervention period, participants will visit the laboratory after fasting overnight. At 8:30 am a cannula will be inserted into a hand vein, with the hand placed in a heating box, for subsequent blood sampling. Indirect calorimetry will be performed to determine energy and changes in the thermic response to a milkshake test drink providing 10 kcals/kg body weight, and comprising 35% of energy as fat, 15% as protein, and 50% as carbohydrate. The SWA will be placed on the upper left arm to estimate energy expenditure. Subsequent blood samples will be obtained every 15 minutes during the next 3 hours in which indirect calorimetry and SWA will be measured concurrently. Fasting blood samples will be used to measure total-, high density lipoprotein (HDL)-, and low density lipoprotein (LDL)-cholesterol, triglycerides, glucose and insulin. Blood samples obtained after the test drink will used to measure glucose, insulin and hormones related to appetite. After that, a test meal (pasta) will be provided as ad-libitum meal and subject will be asked to fill VAS to assess subjective appetite sensations.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Notts
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Nottingham, Notts, Regno Unito, NG72UH
- David Greenfield Human Physiology Unit, University of Nottingham Medical School
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Healthy,
- BMI 18.5-25kg/m2 ,
- Regular menstrual cycles,
- Weight stable over the past 3 months.
Exclusion Criteria:
- pregnant or breast feeding,
- clinically significant abnormalities on screening,
- taking medication other than the contraceptive pill,
- dieting/seeking to lose weight,
- With symptoms of clinical depression,
- With eating disorders,
- Smokers,
- High alcohol consumers.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Irregular meal pattern
Participants will be asked to consume a standard diet, spread over a different number of meals/snacks per day, for a 2week intervention period.
Number of meals will range from 3 to 9 per day.
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Comparatore placebo: Regular Meal Pattern
Participants will be asked to consume a standard diet, spread over 6 of meals/snacks every day, for a 2week intervention period.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in thermic effect of food
Lasso di tempo: After 2 weeks' intervention period
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Thermic effect of food will be measured using ventilated hood Indirect calorimetry when fasted and after consumption of a mixed macronutrient drink, before and after 2 weeks of meal pattern manipulation.
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After 2 weeks' intervention period
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in whole blood glucose response to the test drink
Lasso di tempo: After 2 weeks' intervention period
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Arterialised blood taken from a dorsal hand vein will be analysed using the modified glucose dehydrogenase photometric technique (Hemocue)
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After 2 weeks' intervention period
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Subjective appetite
Lasso di tempo: Before and after 2 weeks' intervention period in response to the test drink, and during the intervention periods
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will be measured by Visual Analogue Scale
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Before and after 2 weeks' intervention period in response to the test drink, and during the intervention periods
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Change in serum insulin concentration
Lasso di tempo: Before and after 2 weeks' intervention period in response to the test drink
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Serum will be analyzed for insulin concentration using a radioimmunoassay
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Before and after 2 weeks' intervention period in response to the test drink
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Change in fasting serum cholesterol (total, LDL and HDL)
Lasso di tempo: Before and after 2 weeks' intervention period
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serum will be analysed using enzymatic photometric test (Horiba)
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Before and after 2 weeks' intervention period
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Change in serum triglycerides concentration
Lasso di tempo: Before and after 2 weeks' intervention period
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Serum will be analysed for triglyceride concentration using enzymic method (Horiba)
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Before and after 2 weeks' intervention period
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Change in incretin hormone response to the test drink
Lasso di tempo: Before and after 2 weeks' intervention period
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Plasma will be analysed for glucagon-like peptide 1 (GLP-1) using an ELISA technique Plasma will also be analysed for Ghrelin and peptide YY (PYY) using radioimmunoassays
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Before and after 2 weeks' intervention period
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P2/13
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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