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

ISRCTN	ISRCTN37829376
DOI	https://doi.org/10.1186/ISRCTN37829376
Protocol serial number	N/A
Sponsor	The Hebrew University of Jerusalem (Israel)
Funders	Meuhedet Medical Services (Israel), Kaplan Medical Center, Rehovot (Israel), Israeli Police Force (Israel), Israel Diabetes Association (Israel), Israel Lung and Tuberculosis Association (Israel)

Submission date: 23/11/2009
Registration date: 03/12/2009
Last edited: 06/02/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Zecharia Madar
Scientific

P.O Box 12
Rehovot
76100
Israel

Phone	+972 (0)89489008
Email	esofer1@012.net.il

Study information

Primary study design	Interventional
Study design	Single centre randomised controlled parallel group trial
Secondary study design	Randomised controlled trial
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.
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(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-α (Human Serum [HS]) and IL-6 (HS) (R&D systems sandwich ELISA kits)
Key secondary outcome measure(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".
Completion date	09/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	80
Key inclusion criteria	1. Police officers from the Israeli Police Force (men and women) 2. Age 25-55 3. BMI >30
Key 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
Date of first enrolment	22/05/2006
Date of final enrolment	09/09/2007

Locations

Countries of recruitment

Israel

Study participating centre

P.O Box 12

Rehovot
76100
Israel

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2013		Yes	No