Enriched Yogurts With Soluble Fibre or Vegetable Protein on Satiety

NCT ID: NCT03625245

Last Updated: 2022-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-10

Study Completion Date

2018-09-30

Brief Summary

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The purpose of this study is to evaluate the satiating effects of different functional yogurts enriched with soluble fiber or vegetable protein on overweight subjects (BMI ≥25 and \<30 kg / m2).

Some studies have shown the contribution of high-fiber foods in the reduction of the cardiovascular risk. On the other hand, protein consumption could have a greater satiety potential compared to other macronutrients.

Detailed Description

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A randomized, cross-over and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of different functional enriched yogurts with soluble fiber or vegetable protein in a group of healthy overweight subjects.

The investigators included 12 participants (6 men and 6 women) between 18 and 55 years (BMI ≥25 and \<30 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products in order during the 3 experimental phases.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Double Blind (Participant and Investigator)

Study Groups

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Control Yogurt

Control yogurt

Group Type PLACEBO_COMPARATOR

Control Yogurt

Intervention Type OTHER

125 g/day

Yogurt Variety 1

Experimental Yogurt 1: Dextrin, wheat bran, whole oatmeal

Group Type EXPERIMENTAL

Yogurt Variety 1

Intervention Type OTHER

125 g/day

Yogurt Variety 2

Experimental Yogurt 2: Pea protein, oatmeal

Group Type EXPERIMENTAL

Yogurt Variety 2

Intervention Type OTHER

125 g/day

Interventions

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Control Yogurt

125 g/day

Intervention Type OTHER

Yogurt Variety 1

125 g/day

Intervention Type OTHER

Yogurt Variety 2

125 g/day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and women from 18 to 65 years old.
* Body Mass Index (BMI) ≥25 and \<30 kg/m2.
* Adequate cultural level and understanding for the clinical trial.
* Signed informed consent

Exclusion Criteria

* Subjects with BMI ≥30 or \<25 kg /m2
* Subjects diagnosed with Diabetes Mellitus.
* Subjects with dyslipidemia on pharmacological treatment
* Subjects with hypertension on pharmacological treatment
* Subjects with established diagnosis of eating disorder
* Smokers or those subjects with high alcohol consumption (\> 2-3 servings/ day in men and\> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer)
* Subjects under pharmacological treatment (except oral contraceptives)
* Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet
* Subjects with sensory problems
* Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients
* Pregnant or breastfeeding women
* Women with menstrual irregularities (absence of menstrual cycle at least 2 months)
* Subjects with intense physical activity.
* Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
* Subjects with a diagnosis of celiac disease or a gluten intolerance
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Go Fruselva, S.L.

UNKNOWN

Sponsor Role collaborator

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmen Gómez Candela, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

La Paz University Hospital

Locations

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La Paz University Hospital

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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5007

Identifier Type: -

Identifier Source: org_study_id

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