A Trial Comparing a Diet Including Products Aimed at Targeting Satiety

NCT02485743 | Completed DMC

• 1 other identifier: NEXS-B292
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weight; Appetite

Keywords

satiation; satiety; weight loss; maintained weight loss

Outcome Measures

Primary Outcomes (1)

• Change in appetite related to change in maintained weight loss

  * 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).

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

Secondary Outcomes (36)

• 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

Study Arms (2)

Active Diet Products

ACTIVE COMPARATOR

A range of products that will be provided as part of a weight maintenance diet which contain active ingredients aimed at increasing satiety (such as inulin, β-glucan, protein and mycoprotein). All ingredients are accepted food ingredients approved for human consumption in Europe.

Other: Active Diet Products

Placebo Diet Products

PLACEBO COMPARATOR

A range of products matching those provided in the Active Diet which will be provided as part of a weight maintenance diet but do not contain additional ingredients aimed at improving satiety (food matrices will be the same - e.g. shakes, cheeses etc but without active ingredients).

Other: Placebo Diet Products

Interventions

Active Diet Products OTHER

A range of Active Diet Products that will be provided as part of a weight maintenance diet which contain active ingredients aimed at increasing satiety (such as inulin, β-glucan, protein, and mycoprotein). All ingredients are accepted food ingredients approved for human consumption in Europe.

Active Diet Products

Placebo Diet Products OTHER

A range of Placebo Diet Products matching those provided in the Active Diet which will be provided as part of a weight maintenance diet but do not contain additional ingredients aimed at improving satiety (food matrices will be the same - e.g. shakes, cheeses etc but without active ingredients).

Placebo Diet Products

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \< 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
• 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)
• Medical conditions as known by the participants:
• Diabetes mellitus (type 1 and 2) (History of gestational diabetes mellitus is allowed)
• Cardiovascular disease including current angina; myocardial infarction; coronary revascularization procedures; stroke (either ischemic or hemorrhagic, including transient ischemic attacks); symptomatic peripheral artery disease that required surgery or was diagnosed with vascular imaging techniques; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure (New York Heart Association Class II or IV); hypertrophic myocardiopathy; and history of aortic aneurism ≥5.5 cm in diameter or aortic aneurism surgery within the past six months, as diagnosed by a medical doctor
• Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, stable treatment (i.e. no change in treatment, either dose, type of medication or other changes) within last 3 months is required
• Chronic kidney disease defined as either kidney damage or estimated Glomerular Filtration Rate (eGFR) of less than 60 mL/min/1.73m2 or Creatinine \>1.5 times upper limit of normal (according to local laboratory reference values) for longer than 3 months as diagnosed by a medical doctor
• Liver disease e.g. cirrhosis (fatty liver disease allowed), or liver dysfunction with transaminases (Alanine Transaminase (ALT) and/or Aspartate Transaminase (ASAT)) more than 3 times the upper limit of normal (according to local laboratory reference values) as diagnosed by a medical doctor

Sponsors & Collaborators

• Professor Jason Halford: lead
• University of Copenhagen: collaborator
• University Rovira i Virgili: collaborator

Study Sites (1)

University of Liverpool

Liverpool, Merseyside, L69 7ZA, United Kingdom

Location

MeSH Terms

Conditions

Body Weight; Weight Loss

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Jason Halford, Professor

  Univeristy of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Jason Halford

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: June 30, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)