Meal Pattern and Metabolic Parameters

NCT02582606 | Completed

• 1 other identifier: P3/15
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Insulin Resistance

Keywords

Insulin Resistance; Meal pattern; Obese

Outcome Measures

Primary Outcomes (1)

• Change in fasting insulin sensitivity, as measured by HOMA-IR

  insulin sensitivity assessed using fasting circulating insulin and glucose concentration and the HOMA-insulin resistance (IR) index

  14 days

Secondary Outcomes (5)

• Change in postprandial circulating insulin concentration

  14 days

• Change in thermic effect of food

  14 days

• Change in subjective appetite

  14 days

• Change in appetite hormones

  14 days

• Change in fasting cholesterol

  14 days

Study Arms (2)

Regular

EXPERIMENTAL

Regular meal pattern

Other: Regular meal pattern

Irregular

EXPERIMENTAL

Irregular meal pattern

Other: Irregular meal pattern

Interventions

Regular meal pattern OTHER

a 14-day period of eating 6 meal per day

Regular

Irregular meal pattern OTHER

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

Irregular

Eligibility Criteria

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

You may qualify if:

• Healthy;
• BMI 28 - 40 kg/m2
• Insulin resistance, HOMA ≥ 1.5
• Weight stable during the last 3 months (self-reported weight change \< ± 2 kg)

You may not qualify if:

• history of serious disease as assessed by a medical screening questionnaire
• taking any medication except for the oral contraceptive pill.
• Smokers
• high alcohol consumers (\< 2-3 units/day),
• pregnant/lactating
• irregular menstrual cycles
• dieting/seeking to lose weight
• clinical symptoms of depression (Beck)
• eating disorder (EAT-26)
• allergy or intolerance to any of the foods provided during each study.

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 (4)

• Farshchi HR, Taylor MA, Macdonald IA. Decreased thermic effect of food after an irregular compared with a regular meal pattern in healthy lean women. Int J Obes Relat Metab Disord. 2004 May;28(5):653-60. doi: 10.1038/sj.ijo.0802616.

  PMID: 15085170 BACKGROUND

• Farshchi HR, Taylor MA, Macdonald IA. Regular meal frequency creates more appropriate insulin sensitivity and lipid profiles compared with irregular meal frequency in healthy lean women. Eur J Clin Nutr. 2004 Jul;58(7):1071-7. doi: 10.1038/sj.ejcn.1601935.

  PMID: 15220950 BACKGROUND

• Farshchi HR, Taylor MA, Macdonald IA. Beneficial metabolic effects of regular meal frequency on dietary thermogenesis, insulin sensitivity, and fasting lipid profiles in healthy obese women. Am J Clin Nutr. 2005 Jan;81(1):16-24. doi: 10.1093/ajcn/81.1.16.

  PMID: 15640455 BACKGROUND

• Alhussain MH, Macdonald IA, Taylor MA. Impact of isoenergetic intake of irregular meal patterns on thermogenesis, glucose metabolism, and appetite: a randomized controlled trial. Am J Clin Nutr. 2022 Jan 11;115(1):284-297. doi: 10.1093/ajcn/nqab323.

  PMID: 34555151 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Obesity

Condition Hierarchy (Ancestors)

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

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: October 16, 2015
• First Posted: October 21, 2015
• Study Start: February 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: May 1, 2015
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

GB (1)