NCT01573988

Brief Summary

In this study, the investigators are interested in assessing the effects of the isocaloric increase of eating frequency on appetite and metabolism. How the consumption of an isocaloric breakfast in four intakes vs. one can modify satiety and appetite control in lean and obese subjects through :

  • the physiological consequences : difference in postprandial kinetics of glucose, non esterified fatty acid, triglyceride, the secretion of satiety gut hormone (insulin, ghrelin, leptin and cholescystokinine (CCK), peptide YY (PYY), glucagon-like peptide-1 (GLP-1), nutrients oxidative fate and plasmatic oxidative stress (Malondialdehyde (MDA), glutathion, lipid hydroperoxides)
  • eating behavior during an ad libitum buffet test meal

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

1.7 years

First QC Date

April 4, 2012

Last Update Submit

September 26, 2012

Conditions

Volunteers

Keywords

NutritionEating frequencyFood intakeEating behaviorSatietyGhrelin

Outcome Measures

Primary Outcomes (1)

  • Ghrelin plasmatic concentration

    240 minutes after breakfast beginning (just before the lunch)

Secondary Outcomes (7)

  • Satiety through food intakes (quantitative) at the ad libitum buffet test meal

    Since the beginning of the buffet test meal (240 minutes after breakfast beginning) to the end of the meal (at the latest 270 minutes after breakfast beginning).

  • Satiety through visual analogue scale

    240 minutes after breakfast beginning (just before the lunch)

  • Plasma metabolite concentrations (glycaemia, non esterified fatty acid,

    kinetics during 430 minutes

  • Endocrine concentrations (insulin, ghrelin, GLP-1, PYY, leptin, C-peptide)

    kinetics during 430 minutes

  • Plasma markers of oxidative stress (MDA, gluthation, lipid hydroxide)

    kinetics during 430 minutes

  • +2 more secondary outcomes

Study Arms (2)

non-obese volunteers

OTHER

Volunteers with a BMI (Body Mass Index) between 20 and 25 kg/m2.

Other: Increasing eating frequency

Obese volunteers

OTHER

Volunteers with a BMI (Body Mass Index) between 30 and 35 kg/m2.

Other: Increasing eating frequency

Interventions

Increasing eating frequencyOTHER

The subjects receive the same breakfast with two sequences : * breakfast in one intake at 8:00 * breakfast in four isocaloric intakes (8:00, 9:00, 10:00, 11:00) The sequence made twice : one for metabolic study and one for the study of eating behavior The lunch during metabolic study is a standard meal The lunch during behavioural study is an ad libitum buffet test meal. The administration order is determined by randomized allocation. The wash-out period is one to three weeks. There are not diet or exercise interventions.

Obese volunteersnon-obese volunteers

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No smokers
  • BMI 20 to 35 kg/m2
  • Moderate physical activity
  • Safety during medical consultation
  • Feeding behavioural phenotype (Dutch Eating Questionnaire, Three Eating Factor Questionnaire)

You may not qualify if:

  • Medical history which may affect glucose metabolism (diabetes, renal or hepatic failure, thyroid dysfunction, Cushing syndrome, acromegaly…)
  • Medical history which affect nutrient absorption (gastro-intestinal and pancreatic disease, gastrectomy, colectomy…)
  • Drug use in the last two months that could affect glucose metabolism (steroids, topical gastric preparation, anorectic drugs…)
  • Eating disorders
  • Claustrophobic subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Lyon Sud - Centre de Recherche en Nutrition Humaine

Pierre-Bénite, 69495, France

Location

Related Links

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 10, 2012

Study Start

August 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations

FR(1)