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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067466
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Laboratorios Ordesa

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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
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 : July 26, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

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




Primary Outcome Measures :
  1. Assessment of satiety using objective methods (blood analysis) [ Time Frame: Change from week 1 to week 2 ]
    Biochemistry : glucose, urea, BUN, creatinin (all in mg/dL)

  2. Assessment of satiety (blood analysis) [ Time Frame: Change from week 1 to week 2 ]
    Biochemistry : GOT and GPT (UI/L)

  3. Assessment of satiety using a subjective method (visual analogue scale) [ Time Frame: 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"."



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067466


Locations
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Spain
GENUD Research Group, Universidad de Zaragoza
Zaragoza, Aragón, Spain, 50009
Sponsors and Collaborators
Laboratorios Ordesa
Investigators
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Principal Investigator: Luis Moreno Aznar Universidad de Zaragoza
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Responsible Party: Laboratorios Ordesa
ClinicalTrials.gov Identifier: NCT04067466    
Other Study ID Numbers: VEGYDOWN-15 (B)
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No