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

Sponsor

Laboratorios Ordesa (Industry)

Overall Status

Completed

CT.gov ID

NCT04067466

Collaborator

(none)

Enrollment

Location

Arms

17.2

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Satiety Appetite	Dietary Supplement: Fiber product Dietary Supplement: Control product	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 26, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Assessment of satiety using objective methods (blood analysis) [Change from week 1 to week 2]
Biochemistry : glucose, urea, BUN, creatinin (all in mg/dL)
Assessment of satiety (blood analysis) [Change from week 1 to week 2]
Biochemistry : GOT and GPT (UI/L)
Assessment of satiety using a subjective method (visual analogue scale) [Change from week 1 to week 2]
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"."

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GENUD Research Group, Universidad de Zaragoza	Zaragoza	Aragón	Spain	50009

Sponsors and Collaborators

Laboratorios Ordesa

Investigators

Principal Investigator: Luis Moreno Aznar, Universidad de Zaragoza

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Laboratorios Ordesa

ClinicalTrials.gov Identifier:

NCT04067466

Other Study ID Numbers:

VEGYDOWN-15 (B)

First Posted:

Aug 26, 2019

Last Update Posted:

Aug 26, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 26, 2019