Influence of the Constancy of Daily Meal Pattern on Energy Balance, Glucose Profiles an Appetite in Healthy Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Nottingham
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Change in thermic effect of food
Study Overview
Brief Summary
In this study we will compare the health effect of two different meal patterns. In one subjects will consume food according to an 'irregular meal pattern' (3-9 meals/day) and the other 'regular meal pattern' (6 meals/day) for two weeks. The energy requirement of the subjects 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, subjects 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, subjects will be assigned to a 2-wk period following one of the two meal-patterns. There will be a 2-week period between the two interventions when subjects 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 a blood glucose monitoring device will be worn for three days. Before and after each 2-week intervention, subjects will come to the lab and will be given a test drink and blood samples will be obtained to evaluate the health effects of the meal patterns. Energy expenditure will be measured by indirect calorimetry. They will then be offered an ad-libitum meal 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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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,
- •High alcohol consumers.
Arms & Interventions
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.
Intervention: Meal pattern (Behavioral)
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.
Intervention: Meal pattern (Behavioral)
Outcomes
Primary Outcomes
Change in thermic effect of food
Time Frame: After 2 weeks' intervention period
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.
Secondary Outcomes
- Change in whole blood glucose response to the test drink(After 2 weeks' intervention period)
Investigators
Elizabeth Simpson
Senior Research Fellow
University of Nottingham