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The Meal Time Study

Primary Purpose

Obesity, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Big Breakfast
Big Dinner
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Weight loss, Chrono-nutrition, Diet, energy expenditure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI ranging from 27-42 kg/m2;
  • Those habitually consuming breakfast (at least 5 times a week).

Exclusion Criteria:

  • women who are pregnant, planning to be pregnant or breastfeeding
  • subjects with food allergies which prevent consumption of the study diet.
  • diagnosis of diabetes, hypertension, renal, hepatic, haematological disease, coronary heart disease, metabolic disease, gastrointestinal disease
  • having given a pint of blood for transfusion purposes within the last month
  • unsuitable veins for blood sampling
  • inability to understand the participant information sheet
  • inability to speak, read and understand the English language
  • those on any prescription medications (other than oral contraceptives) which will adversely affect the study outcomes (i.e. medications affecting, circadian timing, sleep or metabolic function).
  • those on any specific diet regimes
  • those on any weight loss programmes (that may be affecting lifestyle, physical activity and diet).
  • Extremes of chronotypes, sleep patterns and physical activity.

Sites / Locations

  • The Rowett Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

big breakfast (BB) to big dinner (BD)

big dinner (BD) to big breakfast (BB)

Arm Description

Phase 1: no intervention, habitual diet for 4 days and then 4day maintenance diet Phase 2: consumption of BB energy restriction diets for 4 weeks Phase 3: washout for 1 week, controlled maintenance diet Phase 4: consumption of BD energy restriction diets for 4 weeks

Phase 1: no intervention, habitual diet for 4 days and then 4day maintenance diet Phase 2: consumption of BD energy restriction diets for 4 weeks Phase 3: washout for 1 week, controlled maintenance diet Phase 4: consumption of BB energy restriction diets for 4 weeks

Outcomes

Primary Outcome Measures

Energy balance
Change in energy balance during each diet protocol (body weight (kg))

Secondary Outcome Measures

Total Daily Energy Expenditure
Total energy expenditure measured by DLW for the 4 week BB and BD diet phases
Resting Metabolic Rate (RMR)
RMR measured with indirect calorimetry (ventilated hood)
Thermic effect of food (TEF)
TEF measured with indirect calorimetry (ventilated hood) for 6 hours after a breakfast meal
Body Volume
Measured with Air Displacement plethysmography (BODPOD),
Bone Mineral Content
Measured with Dual energy x-ray absorptiometry (DEXA)
Total Body Water
Measured with deuterium dilution
Body Composition
4 compartment model to assess changes in body composition (Combined from the measures of body weight, body volume, total body water and bone mineral)
Gastric emptying
Gastric emptying measured using stable isotope, Octanoic acid labelled breath samples.
Waist and hip circumference
Change in waist and hip circumferences and waist to hip ratio
Gut appetite hormones
Change in plasma fasting and 2 hr post-meal appetite hormones
Plasma glucose
Change in plasma fasting and 2 hr post-meal glucose
Plasma insulin
Change in plasma fasting and 2 hr post-meal insulin
Blood lipids
Change in plasma fasting and 2 hr post-meal blood lipids
Daily Subjective Appetite
Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every waking hour for 3 days.
Postprandial Subjective Appetite
Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every 30 minutes for 6 hours after test meals.
Faecal sample analysis for gut health
Chronic influence on changes in gut microbiota
Physical activity
Change in physical activity levels measured with accelerometer (actigraph)
24 hour blood glucose
Changes in 24 hour blood glucose levels measured with a continuous glucose monitor

Full Information

First Posted
September 26, 2017
Last Updated
April 3, 2020
Sponsor
University of Aberdeen
Collaborators
University of Surrey, Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT03305237
Brief Title
The Meal Time Study
Official Title
The Big Breakfast Study: Chrono-nutrition Influence on Energy Expenditure and Body Weight
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen
Collaborators
University of Surrey, Maastricht University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This weight loss study will investigate the impact of calorie distribution across a day (large breakfast meals and smaller evening meals versus small breakfast meals and large evening meals) on body weight, and physiological and behavioral mechanisms regulating energy balance. Participants will undergo 2 x 4 week energy restriction protocols in a randomized cross over design; big breakfast (45% of calories in the morning meal, 20% at dinner) and big dinner (45% of calories in the evening meal, 20% at breakfast). We predict that timing of eating will influence energy balance, because morning energy expenditure is amplified in comparison to the evening. This study will allow us to assess whether the increased energy expenditure in the morning is linked to natural biological circadian rhythm or behavioral adaptions.
Detailed Description
Dietary advice for weight management is broadly based on the assumption that a 'calorie is a calorie' and it does not matter when calories are consumed across the day. Recent evidence has challenged this assumption, suggesting that we may utilize calories more efficiently when consumed in the morning relative to the evening, and this could be used as a beneficial strategy for weight loss - this is a newly developing field of investigation which merges circadian biology with nutrition (chrono-nutrition). Timing of food consumption is a modifiable factor influencing energy balance and body weight (and thus, disease risk). Previous research has shown that calories ingested at different times of the day have different effects on energy utilization, leading to differential weight loss, even at iso-caloric amounts. This study will aim to increase our understanding of the underlying behavioral and physiological mechanisms associated with differential weight loss and energy balance when calories are consumed predominantly in the morning versus in the evening. This study will be a cross-over study comparing large breakfast versus large evening meals (percent daily calories split between breakfast, lunch and dinner as 45-35-20 (breakfast-loaded) or 20-35-45 (evening-loaded)) during energy restriction (Fed to measured RMR) on energy balance, through differences in both physiological and behavioural changes in energy expenditure and substrate utilization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Weight loss, Chrono-nutrition, Diet, energy expenditure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
big breakfast (BB) to big dinner (BD)
Arm Type
Experimental
Arm Description
Phase 1: no intervention, habitual diet for 4 days and then 4day maintenance diet Phase 2: consumption of BB energy restriction diets for 4 weeks Phase 3: washout for 1 week, controlled maintenance diet Phase 4: consumption of BD energy restriction diets for 4 weeks
Arm Title
big dinner (BD) to big breakfast (BB)
Arm Type
Experimental
Arm Description
Phase 1: no intervention, habitual diet for 4 days and then 4day maintenance diet Phase 2: consumption of BD energy restriction diets for 4 weeks Phase 3: washout for 1 week, controlled maintenance diet Phase 4: consumption of BB energy restriction diets for 4 weeks
Intervention Type
Other
Intervention Name(s)
Big Breakfast
Intervention Description
Weight loss diet (Calories fed to measured RMR) with calories distributed predominantly at breakfast (percent daily calories split between breakfast, lunch and dinner as 45-35-20%). The diet will be high protein (30% protein, 35% fat and 35% CHO) with all meals provided.
Intervention Type
Other
Intervention Name(s)
Big Dinner
Intervention Description
Weight loss diet (Calories fed to measured RMR) with calories distributed predominantly at dinner (percent daily calories split between breakfast, lunch and dinner as 20-35-45%). The diet will be high protein (30% protein, 35% fat and 35% CHO) with all meals provided.
Primary Outcome Measure Information:
Title
Energy balance
Description
Change in energy balance during each diet protocol (body weight (kg))
Time Frame
Measured up to day 71 of study
Secondary Outcome Measure Information:
Title
Total Daily Energy Expenditure
Description
Total energy expenditure measured by DLW for the 4 week BB and BD diet phases
Time Frame
4 x 2 weeks. Throughout weeks 2-5 and 7-10.
Title
Resting Metabolic Rate (RMR)
Description
RMR measured with indirect calorimetry (ventilated hood)
Time Frame
Baseline,week 1, week 5, week 6, week 10.
Title
Thermic effect of food (TEF)
Description
TEF measured with indirect calorimetry (ventilated hood) for 6 hours after a breakfast meal
Time Frame
Week 1, week 5, week 6, week 10.
Title
Body Volume
Description
Measured with Air Displacement plethysmography (BODPOD),
Time Frame
Week 1, week 5, week 6, week 10.
Title
Bone Mineral Content
Description
Measured with Dual energy x-ray absorptiometry (DEXA)
Time Frame
Week 1, week 5, week 6, week 10.
Title
Total Body Water
Description
Measured with deuterium dilution
Time Frame
Week 1, week 5, week 6, week 10.
Title
Body Composition
Description
4 compartment model to assess changes in body composition (Combined from the measures of body weight, body volume, total body water and bone mineral)
Time Frame
Week 1, week 5, week 6, week 10.
Title
Gastric emptying
Description
Gastric emptying measured using stable isotope, Octanoic acid labelled breath samples.
Time Frame
Week 1, week 5, week 6, week 10.
Title
Waist and hip circumference
Description
Change in waist and hip circumferences and waist to hip ratio
Time Frame
Week 1, week 5, week 6, week 10.
Title
Gut appetite hormones
Description
Change in plasma fasting and 2 hr post-meal appetite hormones
Time Frame
Week 1, week 5, week 6, week 10.
Title
Plasma glucose
Description
Change in plasma fasting and 2 hr post-meal glucose
Time Frame
Week 1, week 5, week 6, week 10.
Title
Plasma insulin
Description
Change in plasma fasting and 2 hr post-meal insulin
Time Frame
Week 1, week 5, week 6, week 10.
Title
Blood lipids
Description
Change in plasma fasting and 2 hr post-meal blood lipids
Time Frame
Week 1, week 5, week 6, week 10.
Title
Daily Subjective Appetite
Description
Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every waking hour for 3 days.
Time Frame
Hourly measures for 3 days in week 1,week 5, week 6, week 10.
Title
Postprandial Subjective Appetite
Description
Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every 30 minutes for 6 hours after test meals.
Time Frame
Week 1, week 5, week 6, week 10.
Title
Faecal sample analysis for gut health
Description
Chronic influence on changes in gut microbiota
Time Frame
Week 1, week 5, week 6, week 10.
Title
Physical activity
Description
Change in physical activity levels measured with accelerometer (actigraph)
Time Frame
Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.
Title
24 hour blood glucose
Description
Changes in 24 hour blood glucose levels measured with a continuous glucose monitor
Time Frame
Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI ranging from 27-42 kg/m2; Those habitually consuming breakfast (at least 5 times a week). Exclusion Criteria: women who are pregnant, planning to be pregnant or breastfeeding subjects with food allergies which prevent consumption of the study diet. diagnosis of diabetes, hypertension, renal, hepatic, haematological disease, coronary heart disease, metabolic disease, gastrointestinal disease having given a pint of blood for transfusion purposes within the last month unsuitable veins for blood sampling inability to understand the participant information sheet inability to speak, read and understand the English language those on any prescription medications (other than oral contraceptives) which will adversely affect the study outcomes (i.e. medications affecting, circadian timing, sleep or metabolic function). those on any specific diet regimes those on any weight loss programmes (that may be affecting lifestyle, physical activity and diet). Extremes of chronotypes, sleep patterns and physical activity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra M Johnstone, PhD
Organizational Affiliation
University of Aberdeen
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rowett Institute
City
Aberdeen
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36087576
Citation
Ruddick-Collins LC, Morgan PJ, Fyfe CL, Filipe JAN, Horgan GW, Westerterp KR, Johnston JD, Johnstone AM. Timing of daily calorie loading affects appetite and hunger responses without changes in energy metabolism in healthy subjects with obesity. Cell Metab. 2022 Oct 4;34(10):1472-1485.e6. doi: 10.1016/j.cmet.2022.08.001. Epub 2022 Sep 9.
Results Reference
derived

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The Meal Time Study

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