Satiety, Meal Frequency and Nutritional Aspects (SAFRAN)

This study has been terminated.
(Difficulties in recruiting of volunteers with a BMI (Body Mass Index) between 30 and 35 kg/m2)
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01573988
First received: April 4, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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

Condition Intervention
Volunteers
Other: Increasing eating frequency

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Behavioural and Metabolic Consequences of Increasing Eating Frequency

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Ghrelin plasmatic concentration [ Time Frame: 240 minutes after breakfast beginning (just before the lunch) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Satiety through food intakes (quantitative) at the ad libitum buffet test meal [ Time Frame: 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). ] [ Designated as safety issue: No ]
  • Satiety through visual analogue scale [ Time Frame: 240 minutes after breakfast beginning (just before the lunch) ] [ Designated as safety issue: No ]
  • Plasma metabolite concentrations (glycaemia, non esterified fatty acid, [ Time Frame: kinetics during 430 minutes ] [ Designated as safety issue: No ]
  • Endocrine concentrations (insulin, ghrelin, GLP-1, PYY, leptin, C-peptide) [ Time Frame: kinetics during 430 minutes ] [ Designated as safety issue: No ]
  • Plasma markers of oxidative stress (MDA, gluthation, lipid hydroxide) [ Time Frame: kinetics during 430 minutes ] [ Designated as safety issue: No ]
  • Lipid oxidation [ Time Frame: kinetics during 430 minutes ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: during the buffet test meal (max : 30 minutes) ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: August 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
non-obese volunteers
Volunteers with a BMI (Body Mass Index) between 20 and 25 kg/m2.
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.

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


  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573988

Locations
France
Centre Hospitalier Lyon Sud - Centre de Recherche en Nutrition Humaine
Pierre Bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

Additional Information:
No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01573988     History of Changes
Other Study ID Numbers: 2010.612/16
Study First Received: April 4, 2012
Last Updated: September 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Nutrition
Eating frequency
Food intake
Eating behavior
Satiety
Ghrelin

ClinicalTrials.gov processed this record on August 28, 2014