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Completed

NCT Number: NCT03625245

Enriched Yogurts With Soluble Fibre or Vegetable Protein on Satiety

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

La Paz University Hospital

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control yogurt

Other

125 g/day

Yogurt Variety 1

Other

125 g/day

Yogurt Variety 2

Other

125 g/day

Primary outcomes

  1. Change from Baseline Satiety Hunger Assessment

    Time frame: 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 outcomes

  1. Change from Baseline Blood Hormonal Satiety Markers

    Time frame: Day 1, 8, 15

    GLP1, Peptide YY, Ghrelin, Leptin, GIP, Peptide C

  2. Amount of food consumed in a "food ad libitum"

    Time frame: Day 1, 8, 15

    120 min After eating the study product

  3. Total amount of food consumed in 24h

    Time frame: Day 1, 8, 15

    24h Food Record Method

  4. Change from Baseline Glucose Metabolism Parameters

    Time frame: Day 1, 8, 15

    Glucose

  5. Change from Baseline Lipid Metabolism Parameters

    Time frame: Day 1, 8, 15

    Cholesterol, LDL-C, HDL-C, TG

  6. Anthropometric Parameters

    Time frame: Day 1, 8, 15

    Weight and height will be combined to report BMI in kg/m2

  7. Sensory Perception Test

    Time frame: 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.

  8. Adverse Effects

    Time frame: Day 1, 8, 15

    Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Collaborators

  • Go Fruselva, S.L.

Registry information

Official study 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

Acronym: SACIYOGU

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2018
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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