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Meal Pattern and Metabolic Parameters

NCT02582606 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-03-27

No results posted yet for this study

Summary

In this study investigators will compare the health effect of two different meal patterns. In one, participants will consume food according to an 'irregular meal pattern' (minimum 3 meals, maximum 9 meals per day) and in the other 'regular meal pattern' (6 meals per day) for two weeks. The energy requirement of the participants 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, interested individuals 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, participants will be assigned to a 2-week period following one of the two meal-patterns. There will be a 2-week period between the two interventions when they 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 an interstitial glucose monitoring device will be worn for seven days. Before and after each 2-week intervention, participants will come to the laboratory for a mixed-meal tolerance test. Blood samples will be obtained before and for 3hrs after eating to evaluate the health effects of the meal patterns. Energy expenditure will be measured by ventilated-hood indirect calorimetry and the armband device. At the end of the 3hr post prandial period, participants will be offered an ad libitum pasta lunch 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

Interventions

OTHER

Regular meal pattern

a 14-day period of eating 6 meal per day

OTHER

Irregular meal pattern

a 14-day period of eating between 3 and 9 meal per day

Sponsors & Collaborators

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Ian A Macdonald, PhD · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-10-31
Completion
2015-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582606 on ClinicalTrials.gov