Contact information
Type
Scientific
Primary contact
Prof Zecharia Madar
ORCID ID
Contact details
P.O Box 12
Rehovot
76100
Israel
+972 (0)89489008
esofer1@012.net.il
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised clinical trial examining leptin, ghrelin and adiponectin diurnal profiles modifications, hunger and satiety scores, anthropometric, biochemical and inflammation parameters following a weight loss diet with carbohydrates eaten only at dinner.
Acronym
Study hypothesis
Obesity is often accompanied by uncontrolled hunger, insulin resistance and by the metabolic syndrome. The adipose tissue, "the energy storage site of the body", is also an endocrine organ that synthesizes and secretes a variety of adipocytokines. This includes hormones regulating hunger and satiety and associated with the development of insulin resistance, the metabolic syndrome and inflammation.
Hypotheses:
1. A weight loss diet with carbohydrates eaten only at dinner (the experimental diet) will lead to modifications of the typical diurnal pattern of leptin, and to higher relative concentrations throughout the day, helping experimental diet participants to experience satiety during the day and to better adhere to their diets.
2. Ghrelin's diurnal pattern will be inverted too, leading to the appearance of hunger sensations later in the day.
3. The experimental diet will increase adiponectin concentrations throughout the day, leading to improved insulin resistance, diminished symptoms of the metabolic syndrome and better inflammation profiles.
Ethics approval
Approved by the Regional Committee for Human Experimentation, Kaplan Hospital, Israel in accordance with the Helsinki declaration of 1975 (revised in 1983). (ref: 024/2006)
Study design
Single centre randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Obesity; metabolic syndrome
Intervention
100 officers enrolled to a randomised single centre controlled interventional diet study. 78 Individuals met study criteria and were randomly allocated to the experimental/control groups.
A standard low calorie diet (20% protein, 30-35% fat, 45-50% carbohydrates, 1300-1500 kcal) providing carbohydrates only at dinner (Experimental diet) or a standard low calorie diet (20% protein, 30-35% fat, 45-50% carbohydrates, 1300-1500 kcal), providing carbohydrates throughout the day (control diet) was consumed for 6 months
Blood samples were taken and the participants filled out hunger-satiety scales every 4 hours between 8:00-20:00 at day 0, 7, 90 and 180.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Leptin, ghrelin (total) and adiponectin (High Molecular Weight) (Linco research sandwich ELISA kits)
2. Insulin (Abbot Microparticle Enzyme Immunoassay test kits)
3. Hunger-Satiety Score (H-SSc) a scale of descriptions from hunger to satiety (1= starving, 10= devastatingly full).
4. Glucose (Olympus enzymatic UV test kits)
5. Insulin resistance (Homeostasis Model Assesment)
6. Cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (Olympus enzymatic colour test kits)
7. C-reactive protein (CRP) (Olympus Immunoturbidimetric test kits)
8. TNF-α (Human Serum [HS]) and IL-6 (HS) (R&D systems sandwich ELISA kits)
Secondary outcome measures
1. Weight, abdominal circumference, and percentage of body fat were measured regularly and on day o, 7, 90,180.
2. "Urge to eat" and "preoccupation with thoughts about food".
Overall trial start date
22/05/2006
Overall trial end date
09/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Police officers from the Israeli Police Force (men and women)
2. Age 25-55
3. BMI >30
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Cardiovascular diseases
2. Hypertension
3. Diabetes mellitus or other primary diseases
4. Followed any type of diet regime within a year prior to the study
5. Pregnancy
Recruitment start date
22/05/2006
Recruitment end date
09/09/2007
Locations
Countries of recruitment
Israel
Trial participating centre
P.O Box 12
Rehovot
76100
Israel
Sponsor information
Organisation
The Hebrew University of Jerusalem (Israel)
Sponsor details
The Robert H. Smith Faculty of Agriculture
Food and Environment
The Hebrew University of Jerusalem
Rehovot
76100
Israel
+972 (0)89489008
esofer1@012.net.il
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Meuhedet Medical Services (Israel)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Kaplan Medical Center, Rehovot (Israel)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Israeli Police Force (Israel)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Israel Diabetes Association (Israel)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Israel Lung and Tuberculosis Association (Israel)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22901843
Publication citations
-
Results
Sofer S, Eliraz A, Kaplan S, Voet H, Fink G, Kima T, Madar Z, Changes in daily leptin, ghrelin and adiponectin profiles following a diet with carbohydrates eaten at dinner in obese subjects., Nutr Metab Cardiovasc Dis, 2013, 23, 8, 744-750, doi: 10.1016/j.numecd.2012.04.008.