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Completed

NCT Number: NCT03305237

The Meal Time Study

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Big Breakfast

Other

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

Other

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 outcomes

  1. Energy balance

    Time frame: Measured up to day 71 of study

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

Secondary outcomes

  1. Total Daily Energy Expenditure

    Time frame: 4 x 2 weeks. Throughout weeks 2-5 and 7-10.

    Total energy expenditure measured by DLW for the 4 week BB and BD diet phases

  2. Resting Metabolic Rate (RMR)

    Time frame: Baseline,week 1, week 5, week 6, week 10.

    RMR measured with indirect calorimetry (ventilated hood)

  3. Thermic effect of food (TEF)

    Time frame: Week 1, week 5, week 6, week 10.

    TEF measured with indirect calorimetry (ventilated hood) for 6 hours after a breakfast meal

  4. Body Volume

    Time frame: Week 1, week 5, week 6, week 10.

    Measured with Air Displacement plethysmography (BODPOD),

  5. Bone Mineral Content

    Time frame: Week 1, week 5, week 6, week 10.

    Measured with Dual energy x-ray absorptiometry (DEXA)

  6. Total Body Water

    Time frame: Week 1, week 5, week 6, week 10.

    Measured with deuterium dilution

  7. Body Composition

    Time frame: Week 1, week 5, week 6, week 10.

    4 compartment model to assess changes in body composition (Combined from the measures of body weight, body volume, total body water and bone mineral)

  8. Gastric emptying

    Time frame: Week 1, week 5, week 6, week 10.

    Gastric emptying measured using stable isotope, Octanoic acid labelled breath samples.

  9. Waist and hip circumference

    Time frame: Week 1, week 5, week 6, week 10.

    Change in waist and hip circumferences and waist to hip ratio

  10. Gut appetite hormones

    Time frame: Week 1, week 5, week 6, week 10.

    Change in plasma fasting and 2 hr post-meal appetite hormones

  11. Plasma glucose

    Time frame: Week 1, week 5, week 6, week 10.

    Change in plasma fasting and 2 hr post-meal glucose

  12. Plasma insulin

    Time frame: Week 1, week 5, week 6, week 10.

    Change in plasma fasting and 2 hr post-meal insulin

  13. Blood lipids

    Time frame: Week 1, week 5, week 6, week 10.

    Change in plasma fasting and 2 hr post-meal blood lipids

  14. Daily Subjective Appetite

    Time frame: Hourly measures for 3 days in week 1,week 5, week 6, week 10.

    Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every waking hour for 3 days.

  15. Postprandial Subjective Appetite

    Time frame: Week 1, week 5, week 6, week 10.

    Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every 30 minutes for 6 hours after test meals.

  16. Faecal sample analysis for gut health

    Time frame: Week 1, week 5, week 6, week 10.

    Chronic influence on changes in gut microbiota

  17. Physical activity

    Time frame: Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.

    Change in physical activity levels measured with accelerometer (actigraph)

  18. 24 hour blood glucose

    Time frame: Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.

    Changes in 24 hour blood glucose levels measured with a continuous glucose monitor

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • Maastricht University
  • University of Surrey

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2017
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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