Work Package 2 Phase 1 - Beverages Study

NCT04483180 | Completed

• 1 other identifier: 774293-WP2-P1
• Study Type: interventional
• Target: 69
• Locations: 3 countries
• Sites: 3

Brief Summary

Within the SWEET project (EU funded), in Work Package 2 there are two phases, this study refers to Phase 1 of the SWEET WP2 project, which will be a coordinated trial across 3 intervention centres, University of Navarra (UNAV), University of Liverpool (ULIV) and University of Copenhagen (UCPH). It will involve an acute intervention in 120 individuals to explore initial acceptance, safety and post-prandial effects of 3 S\&SE blends delivered in beverage format. The main endpoints of the SWEET WP2 Phase 1 study will be glycaemic and lipaemic responses; eating behavior (subjective appetite, food preference, cravings, reward), and health effects (rebound hunger, G.I. side effects and metabolic effects). This phase will be exploratory and will not involve any specific primary hypotheses.

Conditions

Glycemic Index; Overweight and Obesity

Outcome Measures

Primary Outcomes (21)

• Blood glucose area under the curve (AUC)

  Area Under the Curve (AUC) for blood glucose (120 min post-intake)

  Clinical Investigation Day 1, 2, 3, 4

• Blood Insulin AUC

  Area Under the Curve for blood Insulin (120 min post-intake)

  Clinical Investigation Day 1, 2, 3, 4

• Hunger iAUC

  Incremental Area Under the Curve for hunger (120 min post-intake)

  Clinical Investigation Day 1, 2, 3, 4

• Fasting Blood glucose

  Fasting blood glucose

  Clinical Investigation Day 1, 2, 3, 4

• 30 min Blood glucose

  Blood glucose at 30 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

• 60 min Blood glucose

  Blood glucose at 60 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

• 90 min Blood glucose

  Blood glucose at 90 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

• 120 min Blood glucose

  Blood glucose at 120 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

• Fasting Blood insulin

  Fasting blood insulin

  Clinical Investigation Day 1, 2, 3, 4

• 30 min Blood insulin

  Blood insulin at 30 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

• 60 min Blood insulin

  Blood insulin at 60 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

• 90 min Blood insulin

  Blood insulin at 90 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

• 120 min Blood insulin

  Blood insulin at 120 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

• Fasting Hunger (VAS registered)

  Fasting subjective appetite questionnaire. Visual Analogue Scale

  Clinical Investigation Day 1, 2, 3, 4

• 5 min Hunger (VAS registered)

  Subjective appetite questionnaire. Visual Analogue Scale at 5 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

• 15 min Hunger (VAS registered)

  Subjective appetite questionnaire. Visual Analogue Scale at 15 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

• 30 min Hunger (VAS registered)

  Subjective appetite questionnaire. Visual Analogue Scale at 30 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

• 45 min Hunger (VAS registered)

  Subjective appetite questionnaire. Visual Analogue Scale at 45 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

• 60 min Hunger (VAS registered)

  Subjective appetite questionnaire. Visual Analogue Scale at 60 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

• 120 min Hunger (VAS registered)

  Subjective appetite questionnaire. Visual Analogue Scale at 120 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

• 180 min Hunger (VAS registered)

  Subjective appetite questionnaire. Visual Analogue Scale at 180 min post-intake

  Clinical Investigation Day 1, 2, 3, 4

Secondary Outcomes (37)

• Fasting Blood cholesterol

  Clinical Investigation Day 1, 2, 3, 4

• 30 min Blood cholesterol

  Clinical Investigation Day 1, 2, 3, 4

• 60 min Blood cholesterol

  Clinical Investigation Day 1, 2, 3, 4

• 90 min Blood cholesterol

  Clinical Investigation Day 1, 2, 3, 4

• 120 min Blood cholesterol

  Clinical Investigation Day 1, 2, 3, 4

Other Outcomes (11)

• Consumers' Perspectives Questionnaire

  Visit 0 (screening)

• Blood DNA Analysis

  Clinical Investigation Day 1

• 24 hour food recall

  Next day after each clinical investigation day (1, 2, 3, 4)

Study Arms (4)

Control

PLACEBO COMPARATOR

Beverage containing a sucrose solution. Same aspect and flavor than the experimental beverages. About 1/4 of participants will start with this beverage first.

Other: Comparison of sweetener blends in liquid form (cross-over study)

Sucralose / acesulfame K

EXPERIMENTAL

Beverage containing a blend of sweeteners based on sucralose and acesulfame K. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first.

Other: Comparison of sweetener blends in liquid form (cross-over study)

Stevia rebaudioside A / thaumatin

EXPERIMENTAL

Beverage containing a blend of sweeteners based on stevia rebaudioside A and thaumatin. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first.

Other: Comparison of sweetener blends in liquid form (cross-over study)

Mogroside V / stevia rebaudioside M

EXPERIMENTAL

Beverage containing a blend of sweeteners based on mogroside V and stevia rebaudioside M. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first.

Other: Comparison of sweetener blends in liquid form (cross-over study)

Interventions

Comparison of sweetener blends in liquid form (cross-over study) OTHER

The aim is to compare the effects of different sweetener blends on glycemia, subjective appetite parameters and safety parameters when consumed in a beverage as part of a breakfast

Control; Mogroside V / stevia rebaudioside M; Stevia rebaudioside A / thaumatin; Sucralose / acesulfame K

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-60 years.
• BMI: 25 to 35 kg/m2.
• For women: Use of contraceptive methods or not planning to become pregnant for the duration of the study.
• Regular consumption of sugar-containing foods and willing to consume artificially-sweetened beverages (a score of ≥ 5 on the short sFFQ Part 1a and answer Yes to all questions in Part 2).
• Able to participate on the visit days/CIDs during normal working hours.
• Healthy as determined from the self-reported medical history or when a clinical condition exists, when this is considered to be irrelevant (i.e. not influencing study outcomes) for the study by the study medical doctor.
• Consuming breakfast regularly (at least 5 days per week).
• Liking of the study foods defined by a response of Yes for each of the breakfast foods during the pre-screening interview and a score of 40 % or above on the Liking VAS for the control beverage.
• Able to understand and be willing to sign the informed consent form, and to follow all the study procedures and requirements.

You may not qualify if:

• Blood donation \< 3 month prior to study.
• Deficient nutrition or hydration status as identified from the pre-screening/screening session (i.e. absence of disease including anaemia, BMI \>18 kg/m2, or other criteria as determined by the study doctor).
• Food allergy, intolerance, restriction or avoidance of any of the study foods (e.g. veganism) or history of anaphylactic reaction to any food.
• Likelihood for disordered eating defined as a score of 20 or more on the EAT-26 test.
• Currently dieting to lose weight or having been on weight cycles (i.e. repeatedly lost and re-gained weight) in the last 3 months.
• Smoking.
• Binge drinking i.e. consuming \>14 units of alcohol per week in women or \>21 units/week in men less than 4 days apart.
• Performing \>10 h of intense physical activity per week.
• Continuous night or late shift work (ending later than 11 pm on a permanent basis). Rotational shift work allowed if can attend on days that do not follow a late/night shift.
• Self-reported use of drugs of abuse within the previous 12 months.
• For women: Pregnancy, lactation.
• Persons who do not have access to either (mobile) phone or internet (this is necessary when being contacted by the study personnel during the study).
• Insufficient communication in the national language.
• Proven or suspected inability, physically or mentally, to comply with the procedures required by the study protocol as evaluated by the daily study manager, site-PI, PI or clinical responsible. This includes volunteers for which insufficient collaboration may be foreseen.
• Subject's general condition contraindicates continuing in the study as evaluated by the daily study manager, site-PI, PI or clinical responsible.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• University of Leeds: collaborator
• University of Copenhagen: collaborator
• University of Liverpool: collaborator
• University of Surrey: collaborator
• Bioiatriki HEALTHCARE GROUP: collaborator

Study Sites (3)

University of Copenhagen

Frederiksberg, Denmark

Location

Centre for Nutrition Research, University of Navarra

Pamplona, Navarre, 31008, Spain

Location

University of Liverpool

Liverpool, United Kingdom

Location

Related Publications (1)

• Almiron-Roig E, Navas-Carretero S, Castelnuovo G, Kjolbaek L, Romo-Hualde A, Normand M, Maloney N, Hardman CA, Hodgkins CE, Moshoyiannis H, Finlayson G, Scott C, Raats MM, Harrold JA, Raben A, Halford JCG, Martinez JA. Impact of acute consumption of beverages containing plant-based or alternative sweetener blends on postprandial appetite, food intake, metabolism, and gastro-intestinal symptoms: Results of the SWEET beverages trial. Appetite. 2023 May 1;184:106515. doi: 10.1016/j.appet.2023.106515. Epub 2023 Feb 26.

  PMID: 36849009 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Cross-Over Studies

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind study. Neither the participant nor the investigator will be aware of the coding of beverages used in the study.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-centre crossover study with 4 conditions using balanced block randomisation. The three centres will follow different randomisation sequences but will all test the same 4 conditions (University of Navarra, University of Copenhagen, University of Liverpool).

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 23, 2020
• Study Start: August 14, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 22, 2022

Record last verified: 2020-06

Locations

DK (1); GB (1); ES (1)