Clinical trial NCT03625245: Enriched Yogurts With Soluble Fibre or Vegetable Protein on Satiety
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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Satiety
Vegetable protein
Yogurt
Fiber
Visual Analogue Scale
Cross-over
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Go Fruselva, S.L.
First posted: 2018-08-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change from Baseline Satiety Hunger Assessment
timeFrame: Day 1, 8, 15
Secondary outcomes:
measure: Change from Baseline Blood Hormonal Satiety Markers
timeFrame: Day 1, 8, 15
measure: Amount of food consumed in a "food ad libitum"
timeFrame: Day 1, 8, 15
measure: Total amount of food consumed in 24h
timeFrame: Day 1, 8, 15
measure: Change from Baseline Glucose Metabolism Parameters
timeFrame: Day 1, 8, 15
measure: Change from Baseline Lipid Metabolism Parameters
timeFrame: Day 1, 8, 15
measure: Anthropometric Parameters
timeFrame: Day 1, 8, 15
measure: Sensory Perception Test
timeFrame: Day 1, 8, 15
measure: Adverse Effects
timeFrame: Day 1, 8, 15
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
affiliation: La Paz University Hospital
name: Carmen Gómez Candela, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: