CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
Regular meal pattern +1 moreother
Likely dose
Not stated in record
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Search/NCT02582606
NCT02582606N/ACompleted

Effects of the Constancy of Daily Meal Pattern on Energy Balance, Glucose Profiles and Plasma Lipoproteins in Obese Women

University of Nottingham·interventional·Posted Oct 21, 2015·Updated Mar 27, 2018

In Brief

A clinical study evaluating Regular meal pattern and Irregular meal pattern for Insulin Resistance. Completed, enrolled 9 participants across 1 site.

Detailed Summary

In this study investigators will compare the health effect of two different meal patterns. In one, participants will consume food according to an 'irregular meal pattern' (minimum 3 meals, maximum 9 meals per day) and in the other 'regular meal pattern' (6 meals per day) for two weeks. The energy requirement of the participants will be calculated to maintain body weight during the study. Participants will be provided with all the food to be consumed during the study. Initially, interested individuals will attend a screening visit in which they will complete questionnaires on medical health, eating habits and physical activity. Height, weight and waist circumference will be measured at this visit. Thereafter, participants will be assigned to a 2-week period following one of the two meal-patterns. There will be a 2-week period between the two interventions when they will consume their normal diet and at the end of this, participants will undertake the next meal pattern. During the two phases participants will be asked to wear an armband (which detects movement and measures heat loss), to assess their energy expenditure and an interstitial glucose monitoring device will be worn for seven days. Before and after each 2-week intervention, participants will come to the laboratory for a mixed-meal tolerance test. Blood samples will be obtained before and for 3hrs after eating to evaluate the health effects of the meal patterns. Energy expenditure will be measured by ventilated-hood indirect calorimetry and the armband device. At the end of the 3hr post prandial period, participants will be offered an ad libitum pasta lunch and be asked to eat until they feel comfortably full. During each of the 2-week periods, participants will be asked to record their food intake and record their appetite sensations on specific days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 21, 2015
Enrollment StartFeb 1, 2014
Primary CompletionOct 1, 2014
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.7 years ago

Interventions

Regular meal patternother

a 14-day period of eating 6 meal per day

Irregular meal patternother

a 14-day period of eating between 3 and 9 meal per day