The Meal Time Study

NCT03305237 | Completed

• 2 other identifiers: 806MR/P012205/1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Weight Loss

Keywords

Weight loss; Chrono-nutrition; Diet; energy expenditure

Outcome Measures

Primary Outcomes (1)

• Energy balance

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

  Measured up to day 71 of study

Secondary Outcomes (18)

• 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.

• 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.

Study Arms (2)

big breakfast (BB) to big dinner (BD)

EXPERIMENTAL

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

Other: Big Breakfast; Other: Big Dinner

big dinner (BD) to big breakfast (BB)

EXPERIMENTAL

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

Other: Big Breakfast; Other: Big Dinner

Interventions

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 breakfast (BB) to big dinner (BD); big dinner (BD) to big breakfast (BB)

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.

big breakfast (BB) to big dinner (BD); big dinner (BD) to big breakfast (BB)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aberdeen: lead
• University of Surrey: collaborator
• Maastricht University: collaborator

Study Sites (1)

The Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36087576 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Alexandra M Johnstone, PhD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 9, 2017
• Study Start: October 24, 2017
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)