A Randomized, Double-blind Multi-centre Trial Comparing a Diet Including Satiating Products Compared to Control Products - SATIN Satiety Diet - Proof of Concept

Professor Jason Halford1 个研究点分布在 1 个国家目标入组 298 人2016年1月

适应症Weight Appetite

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Weight
发起方: Professor Jason Halford
入组人数: 298
试验地点: 1
主要终点: Change in appetite related to change in maintained weight loss
状态: 已完成
最后更新: 6年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

This multi-centre, randomised controlled trial will be conducted over 12-weeks to evaluate whether lower appetite is associated with weight loss maintenance success. The effect of a healthy diet supplemented with products that could enhance feelings of satiety and reduce food intake after an initial weight loss period to assess weight maintenance. Participants will either receive the active SATIN product or a matched control product. The products contain ingredients which have been shown to positively affect satiety, satiation and/or body weight and are all accepted food ingredients approved for human consumption in Europe. They will be incorporated into different food matrices, e.g. drinks, shakes and cheeses. Corresponding control products without the active ingredients will be provided to participants allocated to the control group. The participants will be instructed in detail on how and when to consume the test products. Participants will be 300 adults (BMI >27kg/m2; Age>18years) who will be tested at three research sites (University of Liverpool, United Kingdom; University of Copenhagen, Denmark and University Rovira I Virgili, Spain). Recruitment will be divided between sites. Participants will attend assessments at one of the three research sites continually throughout the study period. The primary outcome is to assess potential associations between changes in appetite (ad libitum energy intake, acute as well as sustained) and change in body weight during the 12-week follow-up period. Secondary outcomes include assessing waist circumference, body composition (DXA), subjective appetite, biomarkers of health outcomes (blood and urine indices), changes in physical activity as well as consumer benefits of the trial (assessed in a range of questionnaires) to determine diet efficacy.

详细描述

The study is a double blinded parallel randomized multicentre study, with six arms. The study will be conducted simultaneously in Denmark, Spain and United Kingdom, at the study sites specified on page 3. A total of 300 participants with an initial BMI of 27 to 35 kg/m2 and a fat mass of no less than 23% will be enrolled in the study. An initial weight loss of a minimum of 8 % will be needed for inclusion in the randomized part of the study. The weight loss will be achieved by administration of a low calorie diet (LCD) for 8 weeks managed by dietician supervised group sessions. Failure to reach at least 8% weight reduction during the LCD will result in exclusion from the intervention. Participants reaching the pre-defined weight loss of no less than 8% will enter a 7-10 days run-in period for diet stabilization before entering the 12-week randomized part of the study. In the randomized part of the study all participants will be advised to follow a general healthy weight loss maintenance diet in accordance with national dietary guidelines. In addition, participants will be randomly allocated in a 1:1 ratio to one of the following intervention groups; 1) including an active satiety enhancing product (active intervention group) or 2) including a similar control product without satiety enhancing properties (control group). For both groups, the participants will be instructed to consume the intervention products daily. Primary study visits for the assessment of body weight, waist circumference, hip circumference, sagittal diameter and blood pressure will be performed at the beginning, and at the end of the intervention period. At least every four weeks during the intervention, the participants will be requested to pick up the study products, and during these visits bodyweight and waist and hip circumference will be recorded. The participants will furthermore meet individually with a dietician three times during the 12 weeks intervention period to enhance compliance with the weight loss maintenance diet and to ensure incorporation of the study specific products into their diet as instructed. Adverse events and concomitant medicine will be registered continuously throughout the study. For each participant, the total study duration is 24 weeks, and includes 17 visits at the study site in total (14+3 appetite probe days)

注册库

clinicaltrials.gov

开始日期

2016年1月

结束日期

2017年7月

最后更新

6年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Professor Jason Halford

责任方

Sponsor Investigator

主要研究者

Professor Jason Halford

University of Liverpool

入排标准

入选标准

•BMI ≥ 27,0 and ≤ 35,0 kg/m2
•Fat mass ≥ 23 % as assessed by bio impedance at the screening visit
•Acceptance of the experimental foods
•Provided voluntary written informed consent

排除标准

•\< 8.0% weight loss during the Low Calorie Diet (LCD) period (will be assessed at visit 7 after having completed the 8 week LCD period)
•Dislike ≥ 25% of the study products (will be assessed at visit 7 through test tasting)
•Known diseases which may affect energy expenditure and/or satiation/satiety/food intake i.e. inflammatory bowel disease, thyroid deceases, major depressions and bipolar deceases
•Eating behaviour characteristics (e.g. restrained eating, disinhibition, emotional eating) identified at the screening visit based on questionnaires
•Weight changes ±3 kg in the last three months
•Dietary patterns interfering with the study protocol, as judged by the Investigator (e.g. vegetarian, vegan, low carb dieters, high fat dieters) two months prior inclusion, during the study or plans to initiate during the study
•Severe food allergies and food intolerances expected to interfere with the study
•Engagement in elite sports or similar strenuous exercise ≥ 5h/week
•Pregnancy or lactation, pregnancy within the past 12 month or plans to become pregnant during the study
•Smoking, smoking cessation within the past three months and/or nicotine use (including electronic cigarettes)

结局指标

主要结局

Change in appetite related to change in maintained weight loss

时间窗: First measured after the 8-week Low Calorie Diet period then over the 12-week intervention period

* Δenergy intake between standard appetite probe day and random appetite probe day before initiating the intervention vs. Δbody weight before initiating the intervention and after completing the intervention (short term/acute effect on appetite) using data from all subjects (active and standard). * Δenergy intake between standard appetite probe day and random appetite probe day after initiating the intervention vs. Δbody weight before initiating the intervention and after completing the intervention (long term effect on appetite) using data from all subjects (active and standard).

次要结局

Change in subjective appetite related to change in maintained weight loss(: First measured after the 8-week Low Calorie Diet period then after the 12-week intervention period)
To test if subjects receiving the active products (enhanced satiating power) will have a better weight-maintenance compared to subjects receiving control products (standard products). This will be tested with the 3 products combined in the main study.(First measured after the 8-week Low Calorie Diet period then after the 12-week intervention period)
Change in body composition(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Biomarkers of appetite/metabolomics (Method: NMR; units; mM)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Biomarkers of appetite/metabolomics (Method: NMR; units: % of FA Chains)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Biomarkers of appetite/metabolomics (Method: LC; units: mM; part 1)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Biomarkers of appetite/metabolomics (Method: LC; units: mM; part 2)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Biomarkers of appetite/metabolomics (Method: LC; units: ng/ml)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Biomarkers of appetite/metabolomics (Method: LC; units: uM; part 1)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Biomarkers of appetite/metabolomics (Method: LC; units: uM; part 2)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Biomarkers of appetite/metabolomics (Method: GC; units: mM)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Biomarkers of appetite/metabolomics (Method: standard enzymatic methods; units: mg/dL)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Biomarkers of appetite/metabolomics (Method: standard enzymatic methods; units: U/L)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Biomarkers of appetite/metabolomics (Method: standard enzymatic methods; units: mU/mL)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Biomarkers of appetite/metabolomics (Method: MAGPIX; units: ug//mL)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Biomarkers of appetite/metabolomics (Method: MAGPIX; units: ng//mL)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Biomarkers of appetite/metabolomics (Method: MAGPIX; units: pg//mL)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Control of Eating Questionnaire (CoEQ)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Three Factor Eating Questionnaire (TFEQ)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Positive and Negative Affect Schedule (PANAS)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Hospital Anxiety and Depression Scale (HADS)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Dutch Eating Behaviour Questionnaire (DEBQ)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Power of Food Scale (PFS)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Mindful Eating Scale (MES)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Eating Self Efficacy Scale (ESES)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Self-consciousness scale (SCSR)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Craving for Sweet Foods(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Weight Self Efficacy Scale (WSES)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Self Report Measure of Quality of Life (EQ-5D)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Impact of Weight on Quality of Life-Lite (IWQOL)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Warwick Edinburgh Mental Well Being Scale (WEMWBS)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Extended Satisfaction with Life Scale (ESWLS)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Perceived Stress Scale(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Pitsburg Sleep Quality Index(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - International Physical Activity Questionnaire (IPAQ)(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)
Consumer benefits - Food Thought Suppression Inventory(Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period)