Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000092897
Ethics application status
Approved
Date submitted
18/01/2012
Date registered
18/01/2012
Date last updated
23/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Assess the Efficacy and Safety of 12 Weeks of Satiereal(R) Supplementation on Food Cravings and Preferences, Body Composition, Satiety and Appetite Regulatory Hormones, and Clinical Safety Markers in Overweight/Obese Individuals
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Assess the Efficacy and Safety of 12 Weeks of Satiereal(R) Supplementation on Food Cravings and Preferences in Overweight/Obese Individuals
Secondary ID [1] 279752 0
'Nil'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
snacking behavior 285614 0
obesity 285615 0
Condition category
Condition code
Diet and Nutrition 285806 285806 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Satiereal is a single patented C sativus stigma extract (Inoreal Ltd, Plerin, France). Satiereal is notified and registered as food supplement in France by the National Trade and Fraud Authority (Direction Generale de la Concurrence, de la Consommation et de la Repression des Fraudes). 88.25 mg twice daily for 12 weeks. The supplement will come in a gelatin capsule
Intervention code [1] 284070 0
Lifestyle
Intervention code [2] 284071 0
Behaviour
Comparator / control treatment
microcrystalline cellulose. 88.25 mg twice daily for 12 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 286319 0
Snacking Frequency (Food Frequency Questionnaire): To determine the effects of the supplement on habitual diet, participants will complete questions regarding frequency with which food items or specific food groups are consumed over a reference period
Timepoint [1] 286319 0
0, 6 and 12 weeks with a 6 week follow up following supplementation cessation
Primary outcome [2] 286320 0
Food Preference Questionnaire:The Food Preference Questionnaire (FPQ) assesses hedonic ratings or ratings of liking for foods in a 2 (High Fat, Low Fat) by 3 (High Simple Sugar, High Complex Carbohydrate, Low Complex Carbohydrate/High Protein) design and will be administered at each testing session. The FPQ consists of 72 foods, with 12 foods in each of six cells: High Fat/High Simple Sugar (HF/HS), High Fat/High Complex Carbohydrate (HF/HC), High Fat/Low Carbohydrate/High Protein (HF/LC/HP), Low Fat/High Simple Sugar (LF/HS), Low Fat/High Complex Carbohydrate (LF/HC), and Low Fat/Low Carbohydrate/High Protein (LF/LC/HP). The HF/HS subscale is composed of foods that are similar to cheesecake, such as chocolate ice cream and fudge brownies. Participants rate each food hedonically on a 9-point Likert scale, with 1 = dislike extremely, 5 = neither like nor dislike, and 9 = like extremely. The FPQ was designed to assess preference for fatty foods by calculating the mean hedonic rating of all high fat foods divided by the mean hedonic rating of all low fat foods.
Timepoint [2] 286320 0
0, 6 and 12 weeks with a 6 week follow up following supplementation cessation
Primary outcome [3] 286322 0
Three Factor Eating Questionnaire: The Three Factor Eating Questionnaire (TFEQ) is a 51-item self-report inventory that assesses Dietary Restraint, Disinhibition, and Perceived Hunger and will be administered at each testing session. Dietary Restraint is conceptualized as the intent and ability to restrict dietary intake, and scores on this subscale have been associated with differences in food intake. Disinhibition refers to the tendency to episodically overeat, often in response to external cues, and Perceived Hunger refers to the subjective state of hunger.
Timepoint [3] 286322 0
0, 6 and 12 weeks with a 6 week follow up following supplementation cessation
Secondary outcome [1] 295600 0
Body Composition Assessments:Total body mass (kg) and waist circumference will be determined with a standard digital scale (Ohaus Champ II) and with standard anthropometric measurements, respectively. Body composition (Fat Mass, Fat Free Mass and Bone Density) will then be determined using a calibrated Hologic Discovery (W) dual energy x ray absorptiometry (DEXA) by qualified personnel. The DEXA body composition test will involve having the subject lie down on their back in a standardized position in a pair of shorts/t-shirt or a gown. A low dose of radiation will then scan their entire body for approximately six (6) minutes. The DEXA segments regions of the body (right arm, left arm, trunk, right leg, and left leg) into three compartments for determination of fat, soft tissue (muscle), and bone mass. Radiation exposure from DEXA for the whole body scan is approximately 1.5mR per scan. The radiation from a total body composition scan is equivalent to less than half a day of natural background radiation. The maximal permissible x-ray dose for non-occupational exposure is 500 mR per year. Total radiation dose will be less than 5mR for the entire study.
Timepoint [1] 295600 0
0, 6 and 12 weeks with a 6 week follow up following supplementation cessation
Secondary outcome [2] 295601 0
Serum concentrations of cortisol, leptin, adiponectin, ghrelin and melatonin and serotonin will be determined in duplicate and the average concentrations reported using commercially available enzyme-linked immunoabsorbent assay (ELISA) kits (Diagnostic Systems Laboratories, Webster, TX; Biosource, Camarillo, CA). Standard curves will be generated for using specific control peptides. Concentrations will be determined at an optical density of 450 nm with a microplate reader (Wallac Victor 1420, Perkin Elmer, Boston MA).
Timepoint [2] 295601 0
0 and 12 weeks with a 6 week follow up following supplementation cessation
Secondary outcome [3] 295602 0
Dietary Analysis and Exercise Activity:To monitor dietary intake and exercise activity during the study, participants will be required to keep four-day dietary records prior to each testing session throughout the duration of the study. The dietary records will be analysed with the Food Processor dietary assessment software program (ESHA Research Inc., Salem, OR). Participants will also complete an exercise diary for each day of the intervention.
Timepoint [3] 295602 0
0, 6 and 12 weeks with a 6 week follow up following supplementation cessation

Eligibility
Key inclusion criteria
Healthy females with a body mass index (BMI) greater than 25 kg/m2 and less than 35 kg/m2.
Minimum age
20 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include recent pregnancy, history of cancer, diabetes (fasting blood glucose greater than 126mg/dL or hemoglobin A1c test greater than 6.5%), pathologic eating disorder, anxiety or depression, abnormal liver or kidney function, concomitant medication or psychotropic drugs or appetite suppressants, gastric surgery, or the use of any dietary supplement that might interfere with the results of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants expressing interest in participating in this study will be interviewed on the phone or in person to determine whether they appear to qualify to participate in this study (Please refer to Key inclusion criteria). Participants believed to meet eligibility criteria will be given a letter to have signed by a physician clearing them to participate in the study. Furthermore, participants will be required to complete blood tests to screen for diabetes and/or abnormal liver/ kidney function. Once physician’s approval and blood tests are complete, participants will be invited to attend a familiarization session. Participants will be familiarized with the study purpose and design and the risks and benefits associated with their participation in this study. They will then read and sign the Informed Consent document (if agreeing to participate) and medical history questionnaires. Participants will then have their body mass and height measured to ensure that they meet the BMI requirements. Supplements will be packaged in identically colored capsules.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomized block design will be utilized where participants will be matched by body composition and reported snacking frequency and randomly divided into 2 groups to ingest either Satierea (Registered Trademark) (88.25 mg; n = 42) or microcrystalline cellulose placebo (88.25 mg; n = 42), twice daily for a period of 12 weeks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2012
Actual
30/07/2012
Date of last participant enrolment
Anticipated
Actual
23/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284537 0
Commercial sector/Industry
Name [1] 284537 0
Nutraveris
Country [1] 284537 0
France
Primary sponsor type
Individual
Name
Matthew Cooke
Address
School of Biomedical & Health Sciences
Faculty of Health, Engineering & Science
Victoria University
PO Box 14428 Melbourne
Country
Australia
Secondary sponsor category [1] 283466 0
Individual
Name [1] 283466 0
Christos Stathis
Address [1] 283466 0
School of Biomedical & Health Sciences
Faculty of Health, Engineering & Science
Victoria University
PO Box 14428 Melbourne
Country [1] 283466 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286525 0
Victoria University Human Research Ethics Committee (VUHREC).
Ethics committee address [1] 286525 0
Office for Research
Victoria University
PO Box 14428
Melbourne, VIC, 8001
Ethics committee country [1] 286525 0
Australia
Date submitted for ethics approval [1] 286525 0
25/01/2012
Approval date [1] 286525 0
26/06/2012
Ethics approval number [1] 286525 0
HRETH 12/27

Summary
Brief summary
The primary purpose of the study is to assess the efficacy and safety of 12 Weeks supplementation of a novel extract of saffron stigma, Satiereal (Registered Trademark) on food cravings and preferences, body composition, satiety and appetite regulatory hormones, and clinical safety markers in overweight/obese individuals. We hypothesize that oral supplementation with Satiereal may reduce snacking and enhance satiety through its suggested mood-improving effect, and thus contribute to weight loss and/or maintenance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33651 0
Dr Matthew Cooke
Address 33651 0
Dr. Matthew Cooke BSc(Hons), PhD
Senior Lecturer
Associate – Institute of Sport, Exercise and Active Living (www.vu.edu.au/iseal)
College of Health and Biomedicine
Victoria University
Office: 6.233 (St.Albans)
Country 33651 0
Australia
Phone 33651 0
61399192566
Fax 33651 0
Email 33651 0
[email protected]
Contact person for public queries
Name 16898 0
Matthew Cooke
Address 16898 0
School of Biomedical & Health Sciences
Faculty of Health, Engineering & Science
Victoria University
PO Box 14428 Melbourne
Country 16898 0
Australia
Phone 16898 0
+61 3 99192566
Fax 16898 0
Email 16898 0
[email protected]
Contact person for scientific queries
Name 7826 0
Matthew Cooke
Address 7826 0
School of Biomedical & Health Sciences
Faculty of Health, Engineering & Science
Victoria University
PO Box 14428 Melbourne
Country 7826 0
Australia
Phone 7826 0
+61 3 99192566
Fax 7826 0
Email 7826 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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