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Clinical Trials/NCT03305237
NCT03305237CompletedNot Applicable

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

University of Aberdeen2 sites in 1 country31 target enrollmentStarted: October 24, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
31
Locations
2
Primary Endpoint
Energy balance

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Energy balance

Time Frame: Measured up to day 71 of study

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

Secondary Outcomes

  • Plasma insulin(Week 1, week 5, week 6, week 10.)
  • Blood lipids(Week 1, week 5, week 6, week 10.)
  • Total Daily Energy Expenditure(4 x 2 weeks. Throughout weeks 2-5 and 7-10.)
  • Resting Metabolic Rate (RMR)(Baseline,week 1, week 5, week 6, week 10.)
  • Gastric emptying(Week 1, week 5, week 6, week 10.)
  • Waist and hip circumference(Week 1, week 5, week 6, week 10.)
  • Gut appetite hormones(Week 1, week 5, week 6, week 10.)
  • Thermic effect of food (TEF)(Week 1, week 5, week 6, week 10.)
  • Body Volume(Week 1, week 5, week 6, week 10.)
  • Bone Mineral Content(Week 1, week 5, week 6, week 10.)
  • Total Body Water(Week 1, week 5, week 6, week 10.)
  • Body Composition(Week 1, week 5, week 6, week 10.)
  • Plasma glucose(Week 1, week 5, week 6, week 10.)
  • Daily Subjective Appetite(Hourly measures for 3 days in week 1,week 5, week 6, week 10.)
  • Postprandial Subjective Appetite(Week 1, week 5, week 6, week 10.)
  • Faecal sample analysis for gut health(Week 1, week 5, week 6, week 10.)
  • Physical activity(Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.)
  • 24 hour blood glucose(Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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