Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/11/2009
Date assigned
03/12/2009
Last edited
06/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22901843

Publication citations

  1. 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.

Additional files

Editorial Notes