Circular Economy and the Design of Healthy and Sustainable Food and Ingredients

NCT05394948 | Completed

• 1 other identifier: ALISSEC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

There is a need to change eating patterns towards healthier diets with new sources of non-animal protein, obtained through more sustainable systems in line with strategies such as the European Green Deal, the "Farm to Fork" strategy, or the Common Agricultural Policy, among others. The objective of this study, is to evaluate the nutritional effect of the developed products and their impact on the improvement and/or prevention of health problems (diabetes, intestinal dysbiosis), as well as to design and evaluation of the effect on health of a vegetable protein-based nutraceutical that also includes fiber and resistant starch.

Conditions

Overweight; Sustainability; Food; Microbiota; Habits

Keywords

Overweight; Microbiota; Sustainability; New food; Food ingredients

Outcome Measures

Primary Outcomes (1)

• Change of fecal microbiota from baseline to week 3.

  Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology.

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).

Secondary Outcomes (15)

• Change of weight from baseline to week 3 (weighing machine)

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).

• Change of body mass index from baseline to week 3.

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).

• Height at baseline.

  The Time Frame contains one time point: Clinical Investigation Day 1 (at baseline).

• Change of waist circumference from baseline to week 3.

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).

• Change of glucose concentration from baseline to week 3.

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).

Study Arms (2)

Group receiving dietary recommendations including experimental nutraceutic.

EXPERIMENTAL

Experimental group will consume experimental nutraceutic instead of the habitual breakfast during 3 weeks and within a dietary recommendations.

Dietary Supplement: Dietary recommendations including experimental nutraceutic.

Group receiving dietary recommendations including control nutraceutic.

ACTIVE COMPARATOR

Experimental group will consume control nutraceutic instead of the habitual breakfast during 3 weeks and within a dietary recommendations.

Dietary Supplement: Dietary recommendations including control nutraceutic.

Interventions

Dietary recommendations including experimental nutraceutic. DIETARY_SUPPLEMENT

Volunteers allocated in the control group will receive every day and during 3 consecutive weeks the experimental nutraceutic instead of the breakfast. Nutraceutical intake will be accompanied by nutritional advice to follow for the 3 weeks of intervention.

Group receiving dietary recommendations including experimental nutraceutic.

Dietary recommendations including control nutraceutic. DIETARY_SUPPLEMENT

Volunteers allocated in the control group will receive every day and during 3 consecutive weeks the control nutraceutic instead of the breakfast. Nutraceutical intake will be accompanied by nutritional advice to follow for the 3 weeks of intervention.

Group receiving dietary recommendations including control nutraceutic.

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: Balanced in men and women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 20-65 years.
• Body mass index: 25-29.9 kg/m2
• Physical examination and vital signs normal or clinically irrelevant to the experiment.
• Volunteers undergoing pharmacological treatment will be maintained if the dose is stable for at least 3 months before the start of the study, excluding treatments that alter gastrointestinal function, antidiabetics and stomach protectors.
• Subjects must be able to understand and be willing to sign the informed consent, and must comply with all the procedures and requirements of the study.
• Subjects have to present a stable weight (+/-3kg) in the three months prior to the start of the study.

You may not qualify if:

• Subjects with relevant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, reflux, etc.
• Subjects with frecuent flatulence, diarrhea and intestinal discomfort.
• Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (for example, gastroduodenostomy).
• Subjects with a high alcohol intake, more than 14 units (women) and 20 units (men).
• Women who are breastfeeding or pregnant.
• Subjects with liver disease.
• Subjects with some type of cancer or undergoing treatment for it, or who have not had a period of at least 5 years since its eradication.
• Subjects with allergies to any component of the product under study or any other food that interferes and makes it difficult to monitor the study.
• Subjects who present some type of cognitive and/or psychic impairment.
• Subjects in whom poor collaboration is expected or who, in the opinion of the investigator, have difficulties in following the study procedures.
• Subjects who follow some type of supplementation that interferes with the study: probiotics, supplements rich in fiber, laxatives, protein supplements, etc.
• Subjects who are immersed in some treatment for weight loss.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

University of Navarra. Center for Nutrition Research.

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Overweight; Habits

Condition Hierarchy (Ancestors)

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

Study Officials

• Fermín I Milagro Yoldi, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 27, 2022
• Study Start: October 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: May 23, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)