SAFRAN: Satiety, Meal Frequency and Nutritional Aspects

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Terminated

CT.gov ID

NCT01573988

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Volunteers	Other: Increasing eating frequency	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Behavioural and Metabolic Consequences of Increasing Eating Frequency

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Other: Obese volunteers

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

Other: Increasing eating frequency

Outcome Measures

Primary Outcome Measures

Ghrelin plasmatic concentration [240 minutes after breakfast beginning (just before the lunch)]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

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