Influence of the Constancy of Daily Meal Pattern on Energy Balance, Glucose Profiles an Appetite in Healthy Women

NCT02052076 | Completed

• 1 other identifier: P2/13
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

In this study we will compare the health effect of two different meal patterns. In one subjects will consume food according to an 'irregular meal pattern' (3-9 meals/day) and the other 'regular meal pattern' (6 meals/day) for two weeks. The energy requirement of the subjects will be calculated to maintain body weight during the study. Participants will be provided with all the food to be consumed during the study. Initially, subjects will attend a screening visit in which they will complete questionnaires on medical health, eating habits and physical activity. Height, weight and waist circumference will be measured at this visit. Thereafter, subjects will be assigned to a 2-wk period following one of the two meal-patterns. There will be a 2-week period between the two interventions when subjects will consume their normal diet and at the end of this, participants will undertake the next meal pattern. During the two phases participants will be asked to wear an armband, which detects movement and measures heat loss, to assess their energy expenditure and a blood glucose monitoring device will be worn for three days. Before and after each 2-week intervention, subjects will come to the lab and will be given a test drink and blood samples will be obtained to evaluate the health effects of the meal patterns. Energy expenditure will be measured by indirect calorimetry. They will then be offered an ad-libitum meal and be asked to eat until they feel comfortably full. During each of the 2-week periods, participants will be asked to record their food intake and record their appetite sensations on specific days.

Conditions

Obesity; Metabolic Syndrome

Keywords

Energy balance; meal pattern; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Change in thermic effect of food

  Thermic effect of food will be measured using ventilated hood Indirect calorimetry when fasted and after consumption of a mixed macronutrient drink, before and after 2 weeks of meal pattern manipulation.

  After 2 weeks' intervention period

Secondary Outcomes (1)

• Change in whole blood glucose response to the test drink

  After 2 weeks' intervention period

Other Outcomes (5)

• Subjective appetite

  Before and after 2 weeks' intervention period in response to the test drink, and during the intervention periods

• Change in serum insulin concentration

  Before and after 2 weeks' intervention period in response to the test drink

• Change in fasting serum cholesterol (total, LDL and HDL)

  Before and after 2 weeks' intervention period

Study Arms (2)

Irregular meal pattern

EXPERIMENTAL

Participants will be asked to consume a standard diet, spread over a different number of meals/snacks per day, for a 2week intervention period. Number of meals will range from 3 to 9 per day.

Behavioral: Meal pattern

Regular Meal Pattern

PLACEBO COMPARATOR

Participants will be asked to consume a standard diet, spread over 6 of meals/snacks every day, for a 2week intervention period.

Behavioral: Meal pattern

Interventions

Meal pattern BEHAVIORAL

Irregular meal pattern; Regular Meal Pattern

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy,
• BMI 18.5-25kg/m2 ,
• Regular menstrual cycles,
• Weight stable over the past 3 months.

You may not qualify if:

• pregnant or breast feeding,
• clinically significant abnormalities on screening,
• taking medication other than the contraceptive pill,
• dieting/seeking to lose weight,
• With symptoms of clinical depression,
• With eating disorders,
• Smokers,
• High alcohol consumers.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

David Greenfield Human Physiology Unit, University of Nottingham Medical School

Nottingham, Notts, NG72UH, United Kingdom

Location

Related Publications (1)

• Alhussain MH, Macdonald IA, Taylor MA. Irregular meal-pattern effects on energy expenditure, metabolism, and appetite regulation: a randomized controlled trial in healthy normal-weight women. Am J Clin Nutr. 2016 Jul;104(1):21-32. doi: 10.3945/ajcn.115.125401. Epub 2016 Jun 15.

  PMID: 27305952 RESULT

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Ian A Macdonald, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: January 31, 2014
• Study Start: January 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: January 1, 2014
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

GB (1)