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 |
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DOI | https://doi.org/10.1186/ISRCTN37829376 |
Secondary identifying numbers | N/A |
- 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
Scientific
P.O Box 12
Rehovot
76100
Israel
Phone | +972 (0)89489008 |
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esofer1@012.net.il |
Study information
Study design | Single centre randomised controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Prevention |
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 | 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 study start date | 22/05/2006 |
Completion date | 09/09/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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
76100
Israel
Sponsor information
The Hebrew University of Jerusalem (Israel)
University/education
University/education
The Robert H. Smith Faculty of Agriculture
Food and Environment
The Hebrew University of Jerusalem
Rehovot
76100
Israel
Phone | +972 (0)89489008 |
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esofer1@012.net.il | |
https://ror.org/03qxff017 |
Funders
Funder type
Other
Meuhedet Medical Services (Israel)
No information available
Kaplan Medical Center, Rehovot (Israel)
No information available
Israeli Police Force (Israel)
No information available
Israel Diabetes Association (Israel)
No information available
Israel Lung and Tuberculosis Association (Israel)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/08/2013 | Yes | No |