The Meal Time Study

Obesity Clinical Trial

Official title:

The Big Breakfast Study: Chrono-nutrition Influence on Energy Expenditure and Body Weight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305237
• Other study ID #: 806
• Secondary ID: MR/P012205/1
• Status: Completed
• Phase: N/A
• Start date: October 24, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2020
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• Big Breakfast
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.
• Big Dinner
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.

Locations

Country	Name	City	State
United Kingdom	The Rowett Institute	Aberdeen

Sponsors (3)

Lead Sponsor	Collaborator
University of Aberdeen	Maastricht University, University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy balance	Change in energy balance during each diet protocol (body weight (kg))	Measured up to day 71 of study
Secondary	Total Daily Energy Expenditure	Total energy expenditure measured by DLW for the 4 week BB and BD diet phases	4 x 2 weeks. Throughout weeks 2-5 and 7-10.
Secondary	Resting Metabolic Rate (RMR)	RMR measured with indirect calorimetry (ventilated hood)	Baseline,week 1, week 5, week 6, week 10.
Secondary	Thermic effect of food (TEF)	TEF measured with indirect calorimetry (ventilated hood) for 6 hours after a breakfast meal	Week 1, week 5, week 6, week 10.
Secondary	Body Volume	Measured with Air Displacement plethysmography (BODPOD),	Week 1, week 5, week 6, week 10.
Secondary	Bone Mineral Content	Measured with Dual energy x-ray absorptiometry (DEXA)	Week 1, week 5, week 6, week 10.
Secondary	Total Body Water	Measured with deuterium dilution	Week 1, week 5, week 6, week 10.
Secondary	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)	Week 1, week 5, week 6, week 10.
Secondary	Gastric emptying	Gastric emptying measured using stable isotope, Octanoic acid labelled breath samples.	Week 1, week 5, week 6, week 10.
Secondary	Waist and hip circumference	Change in waist and hip circumferences and waist to hip ratio	Week 1, week 5, week 6, week 10.
Secondary	Gut appetite hormones	Change in plasma fasting and 2 hr post-meal appetite hormones	Week 1, week 5, week 6, week 10.
Secondary	Plasma glucose	Change in plasma fasting and 2 hr post-meal glucose	Week 1, week 5, week 6, week 10.
Secondary	Plasma insulin	Change in plasma fasting and 2 hr post-meal insulin	Week 1, week 5, week 6, week 10.
Secondary	Blood lipids	Change in plasma fasting and 2 hr post-meal blood lipids	Week 1, week 5, week 6, week 10.
Secondary	Daily Subjective Appetite	Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every waking hour for 3 days.	Hourly measures for 3 days in week 1,week 5, week 6, week 10.
Secondary	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.	Week 1, week 5, week 6, week 10.
Secondary	Faecal sample analysis for gut health	Chronic influence on changes in gut microbiota	Week 1, week 5, week 6, week 10.
Secondary	Physical activity	Change in physical activity levels measured with accelerometer (actigraph)	Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.
Secondary	24 hour blood glucose	Changes in 24 hour blood glucose levels measured with a continuous glucose monitor	Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.