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

NCT04067466 | Completed

• 1 other identifier: VEGYDOWN-15 (B)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Satiety; Appetite

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Fiber product

EXPERIMENTAL

Fiber product: Inulin, maltodextrin, gum guar, plum powder

Dietary Supplement: Fiber product

Control product

PLACEBO COMPARATOR

Maltodextrin, plum powder

Dietary Supplement: Control product

Interventions

Fiber product DIETARY_SUPPLEMENT

Fiber product with inulin, maltodextrin, gum guar and plum powder.

Fiber product

Control product DIETARY_SUPPLEMENT

Placebo product with maltodextrin and plum powder

Control product

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Ordesa: lead

Study Sites (1)

GENUD Research Group, Universidad de Zaragoza

Zaragoza, Aragon, 50009, Spain

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Luis Moreno Aznar

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 26, 2019
• Study Start: July 26, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)