Satiety, Meal Frequency and Nutritional Aspects

Volunteers Clinical Trial

— SAFRAN  

Official title:

Behavioural and Metabolic Consequences of Increasing Eating Frequency

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01573988
• Other study ID #: 2010.612/16
• Status: Terminated
• Phase: N/A
• First received: April 4, 2012
• Last updated: September 26, 2012
• Start date: August 2010
• Est. completion date: April 2012

Study information

• Verified date: September 2012
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Volunteers

Intervention

Other:
• Increasing eating frequency
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud - Centre de Recherche en Nutrition Humaine	Pierre Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ghrelin plasmatic concentration		240 minutes after breakfast beginning (just before the lunch)	No
Secondary	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).	No
Secondary	Satiety through visual analogue scale		240 minutes after breakfast beginning (just before the lunch)	No
Secondary	Plasma metabolite concentrations (glycaemia, non esterified fatty acid,		kinetics during 430 minutes	No
Secondary	Endocrine concentrations (insulin, ghrelin, GLP-1, PYY, leptin, C-peptide)		kinetics during 430 minutes	No
Secondary	Plasma markers of oxidative stress (MDA, gluthation, lipid hydroxide)		kinetics during 430 minutes	No
Secondary	Lipid oxidation		kinetics during 430 minutes	No
Secondary	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)	No

External Links

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