Influence of the Constancy of Daily Meal Pattern on Energy Balance, Glucose Profiles an Appetite in Healthy Women
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

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:

      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.
    

Intervention name(s): Meal pattern
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Energy balance; meal pattern; metabolic syndrome