Appetite Satisfaction and Short-term Satiety of Different Plant Compositions in the Adolescent Age Group

Effect on Appetite Satisfaction and Short-term Satiety of Different Plant Compositions in the Adolescent Age Group

This study evaluates the satiating effect of two types of food supplements made from various types of fibres in the subsequent intake of other foods, in satiety, and in the regulation of hormones

Study Overview

• Status: Completed
• Conditions: Satiety; Appetite
• Intervention / Treatment: Dietary supplement: Fiber product; Dietary supplement: Control product

Detailed Description

This study assessing the effect on appetite satisfaction and short-term satiety of different plant compositions in the adolescent age segment wants to assess the satiating effect of two types of food supplements made with various types of fibers (inulin, maltodextrins, guar gum and dehydrated plums) in the subsequent intake of other foods, in satiety, and in the regulation of hormones (ghrelin, leptin and insulin) and other peptides involved in the mechanisms of satiety

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Aragón
    • Zaragoza, Aragón, Spain, 50009
      • GENUD Research Group, Universidad de Zaragoza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women between 15 and 30 years old.
• Subjects with IMC<25 kg/m2
• Subjects who have a habit of having breakfast, lunch and dinner every day
• Subjects who are willing to comply with the study procedures

Exclusion Criteria:

• Subjects taht are taking any medicines that affect the appetite or food intake
• Presence of endocrine-metabolic diseases
• Eating disorders
• Subjects who are following a special diet
• Subjects who have changed their body weight by more than 10% in the last three months prior to the study
• Subjects who follow a restrictive dietary pattern such as vegetarians, gluten-free diets, weight loss diets, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fiber product; Fiber product: Inulin, maltodextrin, gum guar, plum powder	Dietary supplement: Fiber product; Fiber product with inulin, maltodextrin, gum guar and plum powder.
Placebo Comparator: Control product; Maltodextrin, plum powder	Dietary supplement: Control product; Placebo product with maltodextrin and plum powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of satiety using objective methods (blood analysis)	Biochemistry : glucose, urea, BUN, creatinin (all in mg/dL)	Change from week 1 to week 2
Assessment of satiety (blood analysis)	Biochemistry : GOT and GPT (UI/L)	Change from week 1 to week 2
Assessment of satiety using a subjective method (visual analogue scale)	The perceived feeling of satiety will be measured using the 100mm "Visual Analogue Scale" labeled at a far end with a "mark" to the left of "extremely hungry", and on the other with an "extremely satiated"."	Change from week 1 to week 2

Collaborators and Investigators

• Sponsor: Laboratorios Ordesa
• Investigators: Principal Investigator: Luis Moreno Aznar, Universidad de Zaragoza

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: VEGYDOWN-15 (B)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No