SACIYOGU: Enriched Yogurts With Soluble Fibre or Vegetable Protein on Satiety

Sponsor

Instituto de Investigación Hospital Universitario La Paz (Other)

Overall Status

Completed

CT.gov ID

NCT03625245

Collaborator

Go Fruselva, S.L. (Other)

Enrollment

Location

Arms

4.7

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight	Other: Control Yogurt Other: Yogurt Variety 1 Other: Yogurt Variety 2	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Double Blind (Participant and Investigator)

Primary Purpose:

Other

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

Actual Study Start Date :

May 10, 2018

Actual Primary Completion Date :

May 24, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Yogurt Control yogurt	Other: Control Yogurt 125 g/day
Experimental: Yogurt Variety 1 Experimental Yogurt 1: Dextrin, wheat bran, whole oatmeal	Other: Yogurt Variety 1 125 g/day
Experimental: Yogurt Variety 2 Experimental Yogurt 2: Pea protein, oatmeal	Other: Yogurt Variety 2 125 g/day

Arm

Intervention/Treatment

Placebo Comparator: Control Yogurt

Control yogurt

Other: Control Yogurt

125 g/day

Experimental: Yogurt Variety 1

Experimental Yogurt 1: Dextrin, wheat bran, whole oatmeal

Other: Yogurt Variety 1

125 g/day

Experimental: Yogurt Variety 2

Experimental Yogurt 2: Pea protein, oatmeal

Other: Yogurt Variety 2

125 g/day

Outcome Measures

Primary Outcome Measures

Change from Baseline Satiety Hunger Assessment [Day 1, 8, 15]
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 [Day 1, 8, 15]
GLP1, Peptide YY, Ghrelin, Leptin, GIP, Peptide C
Amount of food consumed in a "food ad libitum" [Day 1, 8, 15]
120 min After eating the study product
Total amount of food consumed in 24h [Day 1, 8, 15]
24h Food Record Method
Change from Baseline Glucose Metabolism Parameters [Day 1, 8, 15]
Glucose
Change from Baseline Lipid Metabolism Parameters [Day 1, 8, 15]
Cholesterol, LDL-C, HDL-C, TG
Anthropometric Parameters [Day 1, 8, 15]
Weight and height will be combined to report BMI in kg/m2
Sensory Perception Test [Day 1, 8, 15]
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 [Day 1, 8, 15]
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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