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Enriched Yogurts With Soluble Fibre or Vegetable Protein on Satiety (SACIYOGU)

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control Yogurt
Yogurt Variety 1
Yogurt Variety 2
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight focused on measuring Satiety, Vegetable protein, Yogurt, Fiber, Visual Analogue Scale, Cross-over

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • La Paz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Control Yogurt

Yogurt Variety 1

Yogurt Variety 2

Arm Description

Control yogurt

Experimental Yogurt 1: Dextrin, wheat bran, whole oatmeal

Experimental Yogurt 2: Pea protein, oatmeal

Outcomes

Primary Outcome Measures

Change from Baseline Satiety Hunger Assessment
Visual Analogue Scale (VAS). 100mm horizontal line anchored at each end with the extremes of the subjective feeling to be quantified. Subjects are instructed to rate the sensation being experienced according to how they define the line. e.g., "not at all hungry" (0mm) and "as hungry as I have ever felt" (100mm). Multiple measures are taken at repeated time intervals described below.

Secondary Outcome Measures

Change from Baseline Blood Hormonal Satiety Markers
GLP1, Peptide YY, Ghrelin, Leptin, GIP, Peptide C
Amount of food consumed in a "food ad libitum"
120 min After eating the study product
Total amount of food consumed in 24h
24h Food Record Method
Change from Baseline Glucose Metabolism Parameters
Glucose
Change from Baseline Lipid Metabolism Parameters
Cholesterol, LDL-C, HDL-C, TG
Anthropometric Parameters
Weight and height will be combined to report BMI in kg/m2
Sensory Perception Test
Questionnaire of analysis of sensory perception of the food study product. Five questions that are valued on a scale of 0% to 100% asking about the taste and smell of the study product: desire with which the product is taken, taste, smell, consistency and what wait for effectiveness.
Adverse Effects
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)

Full Information

First Posted
May 9, 2018
Last Updated
January 12, 2022
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Go Fruselva, S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT03625245
Brief Title
Enriched Yogurts With Soluble Fibre or Vegetable Protein on Satiety
Acronym
SACIYOGU
Official Title
Pilot Study to Evaluate the Satiating Effect of Enriched Functional Yogurts With Soluble Fibre or Vegetable Protein in a Group of Healthy Overweight Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
May 24, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Go Fruselva, S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Satiety, Vegetable protein, Yogurt, Fiber, Visual Analogue Scale, Cross-over

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Double Blind (Participant and Investigator)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Yogurt
Arm Type
Placebo Comparator
Arm Description
Control yogurt
Arm Title
Yogurt Variety 1
Arm Type
Experimental
Arm Description
Experimental Yogurt 1: Dextrin, wheat bran, whole oatmeal
Arm Title
Yogurt Variety 2
Arm Type
Experimental
Arm Description
Experimental Yogurt 2: Pea protein, oatmeal
Intervention Type
Other
Intervention Name(s)
Control Yogurt
Intervention Description
125 g/day
Intervention Type
Other
Intervention Name(s)
Yogurt Variety 1
Intervention Description
125 g/day
Intervention Type
Other
Intervention Name(s)
Yogurt Variety 2
Intervention Description
125 g/day
Primary Outcome Measure Information:
Title
Change from Baseline Satiety Hunger Assessment
Description
Visual Analogue Scale (VAS). 100mm horizontal line anchored at each end with the extremes of the subjective feeling to be quantified. Subjects are instructed to rate the sensation being experienced according to how they define the line. e.g., "not at all hungry" (0mm) and "as hungry as I have ever felt" (100mm). Multiple measures are taken at repeated time intervals described below.
Time Frame
Day 1, 8, 15
Secondary Outcome Measure Information:
Title
Change from Baseline Blood Hormonal Satiety Markers
Description
GLP1, Peptide YY, Ghrelin, Leptin, GIP, Peptide C
Time Frame
Day 1, 8, 15
Title
Amount of food consumed in a "food ad libitum"
Description
120 min After eating the study product
Time Frame
Day 1, 8, 15
Title
Total amount of food consumed in 24h
Description
24h Food Record Method
Time Frame
Day 1, 8, 15
Title
Change from Baseline Glucose Metabolism Parameters
Description
Glucose
Time Frame
Day 1, 8, 15
Title
Change from Baseline Lipid Metabolism Parameters
Description
Cholesterol, LDL-C, HDL-C, TG
Time Frame
Day 1, 8, 15
Title
Anthropometric Parameters
Description
Weight and height will be combined to report BMI in kg/m2
Time Frame
Day 1, 8, 15
Title
Sensory Perception Test
Description
Questionnaire of analysis of sensory perception of the food study product. Five questions that are valued on a scale of 0% to 100% asking about the taste and smell of the study product: desire with which the product is taken, taste, smell, consistency and what wait for effectiveness.
Time Frame
Day 1, 8, 15
Title
Adverse Effects
Description
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Time Frame
Day 1, 8, 15

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
6 men and 6 women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gómez Candela, MD, PhD
Organizational Affiliation
La Paz University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Paz University Hospital
City
Madrid
Country
Spain

12. IPD Sharing Statement

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Enriched Yogurts With Soluble Fibre or Vegetable Protein on Satiety

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