Hormonal profiles modification, lower hunger scores, better anthropometric outcomes and reduced risk factors of the metabolic syndrome following a weight loss diet with carbohydrates eaten only at dinner

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN37829376
• Date of registration: 03/12/2009
• Primary sponsor: The Hebrew University of Jerusalem (Israel)
• Public title: Hormonal profiles modification, lower hunger scores, better anthropometric outcomes and reduced risk factors of the metabolic syndrome following a weight loss diet with carbohydrates eaten only at dinner N/A
• 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.
• Date of first enrolment: May 22 2006
• Target sample size: 80
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN37829376
• Study type: Interventional
• Study design: Single centre randomised controlled parallel group trial

Countries of recruitment

Israel

Contacts

• Name: Zecharia Madar

Key inclusion & exclusion criteria

Inclusion criteria: 1. Police officers from the Israeli Police Force (men and women)
2. Age 25-55
3. BMI >30
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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Obesity; metabolic syndrome

Intervention(s)

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.

Primary Outcome(s)

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-a (Human Serum [HS]) and IL-6 (HS) (R&D systems sandwich ELISA kits)

Secondary Outcome(s)

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".

Secondary ID(s)

N/A

Source(s) of Monetary Support

1. Meuhedet Medical Services (Israel) 2. Kaplan Medical Center, Rehovot (Israel) 3. Israeli Police Force (Israel) 4. Israel Diabetes Association (Israel) 5. Israel Lung and Tuberculosis Association (Israel)

Secondary Sponsor(s)

N/A