- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02052076
Influence of the Constancy of Daily Meal Pattern on Energy Balance, Glucose Profiles an Appetite in Healthy Women
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Notts
-
Nottingham, Notts, United Kingdom, NG72UH
- David Greenfield Human Physiology Unit, University of Nottingham Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
|
Placebo Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
After 2 weeks' intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in whole blood glucose response to the test drink
Time Frame: After 2 weeks' intervention period
|
Arterialised blood taken from a dorsal hand vein will be analysed using the modified glucose dehydrogenase photometric technique (Hemocue)
|
After 2 weeks' intervention period
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective appetite
Time Frame: Before and after 2 weeks' intervention period in response to the test drink, and during the intervention periods
|
will be measured by Visual Analogue Scale
|
Before and after 2 weeks' intervention period in response to the test drink, and during the intervention periods
|
Change in serum insulin concentration
Time Frame: Before and after 2 weeks' intervention period in response to the test drink
|
Serum will be analyzed for insulin concentration using a radioimmunoassay
|
Before and after 2 weeks' intervention period in response to the test drink
|
Change in fasting serum cholesterol (total, LDL and HDL)
Time Frame: Before and after 2 weeks' intervention period
|
serum will be analysed using enzymatic photometric test (Horiba)
|
Before and after 2 weeks' intervention period
|
Change in serum triglycerides concentration
Time Frame: Before and after 2 weeks' intervention period
|
Serum will be analysed for triglyceride concentration using enzymic method (Horiba)
|
Before and after 2 weeks' intervention period
|
Change in incretin hormone response to the test drink
Time Frame: Before and after 2 weeks' intervention period
|
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
|
Before and after 2 weeks' intervention period
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2/13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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