Effects of the Constancy of Daily Meal Pattern on Energy Balance, Glucose Profiles and Plasma Lipoproteins in Obese Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Nottingham
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Change in fasting insulin sensitivity, as measured by HOMA-IR
Study Overview
Brief 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.
Detailed Description
Background. Greater variation in meal pattern from day to day might affect energy balance and, in consequence, the control of body weight. However, studies which have evaluated the impact of an irregular meal pattern on energy metabolism, in adults, are few. Several experimental studies by Farshchi et al. have shown that there are potentially important negative health consequences associated with erratic/irregular eating patterns. Higher fasting levels of total-cholesterol and low density lipoprotein (LDL)-cholesterol, a decrease in thermic effect of food (TEF), and reduced insulin sensitivity, were observed in healthy women after 14 days of irregular eating. Subsequent studies have confirmed this in overweight subjects and also provided evidence of alterations in subjective appetite which may influence ad-libitum food intake (Lara et al, unpublished).
Recently, experimenters have shown a decrease in thermogenesis in response to a test meal, and greater postprandial blood glucose concentration in 11 normal weight women following two-weeks of irregular eating in contrast to a regular pattern.
The present study will study the effect of an irregular meal pattern in obese women who demonstrate fasting insulin resistance (IR).
Aims:
to investigate the effects of meal pattern on energy expenditure, postprandial thermogenesis, postprandial blood glucose, fasting lipid profile and fasting insulin sensitivity in obese women with insulin resistance.
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 28 - 40 kg/m2
- •Insulin resistance, HOMA ≥ 1.5
- •Weight stable during the last 3 months (self-reported weight change < ± 2 kg)
Exclusion Criteria
- •history of serious disease as assessed by a medical screening questionnaire
- •taking any medication except for the oral contraceptive pill.
- •high alcohol consumers (< 2-3 units/day),
- •pregnant/lactating
- •irregular menstrual cycles
- •dieting/seeking to lose weight
- •clinical symptoms of depression (Beck)
- •eating disorder (EAT-26)
- •allergy or intolerance to any of the foods provided during each study.
Arms & Interventions
Regular
Regular meal pattern
Intervention: Regular meal pattern (Other)
Irregular
Irregular meal pattern
Intervention: Irregular meal pattern (Other)
Outcomes
Primary Outcomes
Change in fasting insulin sensitivity, as measured by HOMA-IR
Time Frame: 14 days
insulin sensitivity assessed using fasting circulating insulin and glucose concentration and the HOMA-insulin resistance (IR) index
Secondary Outcomes
- Change in thermic effect of food(14 days)
- Change in postprandial circulating insulin concentration(14 days)
- Change in subjective appetite(14 days)
- Change in fasting cholesterol(14 days)
- Change in appetite hormones(14 days)
Investigators
Elizabeth Simpson
Senior Research Fellow
University of Nottingham