Meat Derivative and Satiating Compound Effect on Satiety

NCT04088812 | Completed DMC

• 1 other identifier: HULP 5389
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the satiating effects of a meat derivative and a satiating compound on overweight subjects (BMI ≥25 and \<30 kg / m2).

Conditions

Overweight

Keywords

Satiety; Meat derivative; Fiber; Visual Analogue Scale; Parallel

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Satiety Hunger Assessment

  Visual Analogue Scale (VAS). 100 mm 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.

  0 min to 240 min

Secondary Outcomes (6)

• Change from Baseline Blood Hormonal Satiety Markers

  0 min to 240 min

• Amount of food consumed in a "food ad libitum"

  240 min

• Total amount of food consumed in 24h

  24 hours

• Change from Baseline Glucose Metabolism Parameters

  0 min to 240 min

• Anthropometric Parameters

  24 hours

Study Arms (3)

Placebo meat derivative + Placebo satiating compound

PLACEBO COMPARATOR

60 g Placebo meat derivative 25 g Placebo satiating compound

Other: Placebo meat derivative + Placebo satiating compound; Other: Placebo meat derivative + Satiating compound; Other: Experimental meat derivative + Placebo satiating control

Placebo meat derivative + Satiating compound

EXPERIMENTAL

60 g Placebo meat derivative 25 g Satiating compound

Other: Placebo meat derivative + Placebo satiating compound; Other: Placebo meat derivative + Satiating compound; Other: Experimental meat derivative + Placebo satiating control

Experimental meat derivative + Placebo satiating control

EXPERIMENTAL

60 g Experimental meat derivative 25 g Placebo satiating compound

Other: Placebo meat derivative + Placebo satiating compound; Other: Placebo meat derivative + Satiating compound; Other: Experimental meat derivative + Placebo satiating control

Interventions

Placebo meat derivative + Placebo satiating compound OTHER

Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound placebo diluted in water

Experimental meat derivative + Placebo satiating control; Placebo meat derivative + Placebo satiating compound; Placebo meat derivative + Satiating compound

Placebo meat derivative + Satiating compound OTHER

Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound diluted in water

Experimental meat derivative + Placebo satiating control; Placebo meat derivative + Placebo satiating compound; Placebo meat derivative + Satiating compound

Experimental meat derivative + Placebo satiating control OTHER

Subjects will consume 60 g of the experimental meat derivative in a brunch type meal with 25 g of satiating compound placebo diluted in water

Experimental meat derivative + Placebo satiating control; Placebo meat derivative + Placebo satiating compound; Placebo meat derivative + Satiating compound

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: 10 men and 10 women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects willing to consume all food present in the brunch type meal.
• Signed informed consent.

You may not qualify if:

• Subjects with BMI ≥30 or \<25 kg /m2. Subjects with a vegetarian diet or with a great fiber consumption (\> 30 g/day)
• Subjects diagnosed with Diabetes Mellitus.
• Subjects with dyslipidemia on pharmacological treatment.
• Subjects with hypertension on pharmacological treatment.
• Subjects with hyper/hypothyroidism.
• 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 gastrointestinal diseases that affect the digestion or absorption of nutrients.
• Subjects with severe chronic diseases (hepatic, kidney, …)
• 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.
• Subjects who consume regularly oral supplements (i.e. omega-3)

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Creaciones Aromáticas Industriales, S.A. (CARINSA): collaborator

Study Sites (1)

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bricia López Plaza, PhD

  La Paz University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 13, 2019
• Study Start: October 11, 2019
• Primary Completion: October 31, 2019
• Study Completion: January 25, 2020
• Last Updated: March 4, 2020

Record last verified: 2020-02

Locations

ES (1)