Repetitive Lipid Intake and Food Intake

NCT03901157 | Unknown

• 1 other identifier: NL66473.068.19
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

In the present study the investigators will investigate the effect of consuming lipids inside alginate gel once a day during 4 days on food intake and satiety feelings in healthy people with overweight. All participants will receive a test yogurt that includes the oil-filled Ca-alginate gels and a control yogurt where the oil is not inside the gels.

Conditions

Satiation; Overweight and Obesity; Satiety Response

Keywords

satiety; lipids in alginate gel; food intake

Outcome Measures

Primary Outcomes (1)

• Repetitive effect on ad libitum food intake

  Food intake of ad libitum meal (kcal), as measured during lunch (based on cumulated weight reduction of the food items provided) and during a pasta dinner (also based on weight reduction of the plate assuming a homogenous meal) after 4 days of consumption of the test product.

  4 days

Secondary Outcomes (5)

• Acute effect on ad libitum food intake

  3 and 6 hours

• Acute vs repetitive on ad libitum food intake

  1 day and 4 days

• Food intake in normal living setting

  2 and 3 days

• Feelings of satiety and GI symptoms (VAS scores)

  1 day and 4 days

• Energy intake compensation

  1 day and 4 days

Study Arms (2)

Active yogurt

EXPERIMENTAL

Contains 120 g yogurt + 60 g oil-gel particles (containing 6 g oil) + 24 g water

Dietary Supplement: Yogurt A: Active

Control yogurt

ACTIVE COMPARATOR

Contains 120 g yogurt + 54 g empty gel particles + 6 g oil in 24 g water

Dietary Supplement: Yogurt B: Control

Interventions

Yogurt A: Active DIETARY_SUPPLEMENT

Free fat yogurt containing oil-filled alginate gels

Active yogurt

Yogurt B: Control DIETARY_SUPPLEMENT

Free fat yogurt containing the same amount of fat as the active one, and empty alginate gels

Control yogurt

Eligibility Criteria

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

You may qualify if:

• Based on medical history and previous examination, no serious gastrointestinal complaints can be defined;
• Age between 18 and 65 years. This study will include healthy adult subjects (male and female);
• BMI between 25-30 kg/m2;
• Able to participate in the study, willing to give informed consent and to comply with the study procedures and restrictions;
• Weight stable over at least the last 6 months (self-admitted; ≤5% weight change).

You may not qualify if:

• Self-admitted milk (-protein or lactose)- allergy/intolerance;
• Self-admitted history of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, haematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided and documented by the principal investigator;
• Use of medication that can influence study end-points (to be decided by medical doctor and principal investigator), including vitamin supplementation, within 14 days prior to testing;
• Administration of investigational drugs or participation in any scientific intervention study that may interfere with this study, to be decided by the principal investigator prior to the study;
• Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery) upon judgement of the principal investigator;
• Dieting (medically prescribed, diabetic and vegetarian);
• Pregnancy, lactation (both self-admitted);
• Excessive alcohol consumption (\>20 alcoholic units per week);
• Smoking;
• Self-admitted HIV-positive state.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Centre for Healthy Eating and Food Innovation

Venlo, Limburg, 5928 RC, Netherlands

RECRUITING

Related Publications (53)

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Related Links

• Obesity and overweight

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Freddy Troost, Dr.

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alvaro R Garcia Fuentes

CONTACT

+31433883182; a.garciafuentes@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 3, 2019
• Study Start: October 21, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)