Effect of a Low-calorie Diet With a Prebiotic Supplement on Health of Overweight-obese Subjects.

NCT06710106 | Completed

• 1 other identifier: POSTBIOTICS (2024.154)
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this project is to evaluate the effect of prebiotic supplementation on weight loss and other physiological and metabolic parameters related to excess weight in overweight/obese adult men and women, as well as to determine the changes in the gut microbiota associated with these changes. Specific objectives are focus on evaluate the effect of the intervention on the following parameters:

• Weight and body composition.
• Changes in the gut microbiota (metagenomics).
• Changes in urinary and serum metabolites.
• Complete blood count, routine biochemical variables related to glucose and lipid metabolism, as well as liver health parameters.
• Specific markers involved in obesity pathology (insulin, leptin, adiponectin, and cytokines MCP1, TNF, CRP, and IL10).
• Satiety-related variables using a visual analog scale.
• Adherence to the assigned intervention, both to the hypocaloric diet and to the supplement provided in the study.
• Physical activity level.
• Changes in gastrointestinal health through self-reported questionnaires.
• Mental health and quality of life of participants through self-reported questionnaires.
• Chronotype of participants through a self-reported questionnaire. For this purpose, a randomized, double blind parallel study has been designed. Target sample size is 156 subjects. Participants will be allocated in two groups for 8 weeks:
• Experimental group (n=104): hypocaloric diet + prebiotic supplement.
• Placebo group (n=52): hypocaloric diet + placebo supplement. Participants will visit nutritional intervention unit at week 1 and week 8. At week 4 they will receive a phone control call.

Conditions

Polyphenols; Obesity; Weight Loss

Keywords

supplement; obesity; polyphenols; prebiotic; microbiota

Outcome Measures

Primary Outcomes (1)

• Fecal microbiota

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

  Clinical Investigation Day 1 and Clinical Investigation Day 2

Secondary Outcomes (47)

• Body weight

  Clinical Investigation Day 1 and Clinical Investigation Day 2

• Height

  Clinical Investigation Day 1

• Body mass index

  Clinical Investigation Day 1 and Clinical Investigation Day 2

• Body fat percentage

  Clinical Investigation Day 1 and Clinical Investigation Day 2

• Body muscle mass

  Clinical Investigation Day 1 and Clinical Investigation Day 2

Study Arms (2)

Prebiotic group

EXPERIMENTAL

Natural yogurt with prebiotic formula

Dietary Supplement: Prebiotic + hypocaloric diet

Placebo group

PLACEBO COMPARATOR

Natural yogurt with placebo formula

Dietary Supplement: Placebo + hypocaloric diet

Interventions

Prebiotic + hypocaloric diet DIETARY_SUPPLEMENT

Study participants will add prebiotic formula in a natural yogurt every day to be consumed within a hypocaloric diet.

Prebiotic group

Placebo + hypocaloric diet DIETARY_SUPPLEMENT

Study participants will add placebo formula in a natural yogurt every day to be consumed within a hypocaloric diet.

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 to 70 years.
• Volunteers with overweight or obesity (BMI: 25.0-39.9 kg/m²) and body fat percentage \> 30% for women / \> 20% for men.
• Stable weight (+/- 5%) in the last three months prior to the start of the study.
• Normal physical examination and vital signs, or clinically insignificant findings for the experiment (those not related to metabolic health).
• Subjects must be able to understand and be willing to sign the informed consent form, agreeing to comply with all study procedures and requirements.
• Willingness to undergo each of the procedures involved in the study (including consuming a sweetened yogurt).
• Availability to attend the two in-person clinical evaluation sessions at the scheduled times and locations.

You may not qualify if:

• That alter gastrointestinal function.
• Stomach protectants.
• Hypoglycemic drugs.
• Insulin (under no circumstances).
• 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 who have undergone surgical interventions with permanent sequelae in the digestive system (e.g., gastroduodenostomy) or bariatric surgery.
• Exceeding the alcohol consumption limit for the corresponding sex (more than 14 units per week for women and 20 units per week for men).
• Pregnant, breastfeeding, or planning to become pregnant.
• Taking nutritional supplementation (weight loss supplements, fiber supplements, probiotics, multivitamins, etc.) that contains compounds that may affect the study outcomes, unless the person is willing to stop these supplements during the 8-week intervention period and ensures a minimum washout period of 30 days before baseline measurements.
• Having donated blood in the 14 days prior to the start visit.
• Subjects with any type of cancer or undergoing cancer treatment, or who have not been free of cancer for at least 5 years since eradication.
• Subjects with an allergy to any component of the study product or any other food that interferes with and complicates following the study protocol.
• Subjects with any cognitive and/or psychiatric impairment.
• Subjects who are expected to have poor cooperation or, in the investigator's opinion, have difficulty following the study procedures.
• Subjects currently undergoing treatment for weight loss/body composition modification.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Center for Nutrition Research

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Idoia Ibero, PhD

  Center for Nutrition Research

  STUDY CHAIR

• María Hernández

  Center for Nutrition Research

  STUDY CHAIR

• Blanca Martínez

  Center for Nutrition Research

  STUDY CHAIR

• Verónica Ciaurriz

  Center for Nutrition Research

  STUDY CHAIR

• Carlos González, PhD

  Center for Nutrition Research

  STUDY CHAIR

• Salomé Pérez

  Center for Nutrition Research

  STUDY CHAIR

• Marta Cuervo, PhD

  Center for Nutrition Research

  STUDY CHAIR

• Ana Lorente

  Center for Nutrition Research

  STUDY CHAIR

• María Goñi

  Center for Nutrition Research

  STUDY CHAIR

Study Design

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

Model Details: Parallel groups, blind, 8-week randomized nutritional intervention

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: December 13, 2024
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)