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Clinical Trials/NCT01573988
NCT01573988TerminatedNot Applicable

Behavioural and Metabolic Consequences of Increasing Eating Frequency

Hospices Civils de Lyon1 site in 1 country37 target enrollmentStarted: August 1, 2010Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
37
Locations
1
Primary Endpoint
Ghrelin plasmatic concentration
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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)

Exclusion Criteria

  • •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

Arms & Interventions

non-obese volunteers

Other

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

Intervention: Increasing eating frequency (Other)

Obese volunteers

Other

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

Intervention: Increasing eating frequency (Other)

Outcomes

Primary Outcomes

Ghrelin plasmatic concentration

Time Frame: 240 minutes after breakfast beginning (just before the lunch)

Secondary Outcomes

  • 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)
  • Lipid oxidation(kinetics during 430 minutes)
  • Eating behaviour at the buffet test meal by video recording (food choice, nutritional composition of the meal , kinetics of nutrient intake, meal structure, lunch duration)(during the buffet test meal (max : 30 minutes))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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