Effect of a Protein Intake on Weight Loss of Overweight/Obese Adults

NCT05368311 | Completed

• 1 other identifier: COLABOCO
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is considered the epidemic of the 21st century. Obesity is a multifactorial disease and the most important risk factors are poor diet and sedentary lifestyle. An excessive body weight contributes to increase the risk of suffering from other diseases and mortality rates. Therefore, the prevention and control of excessive body weight as well as its comorbidities are essential. In this sense, the principal strategy to treat obesity is to improve dietary habits and increase physical activity. However, the rate of obesity continues rising. In order to deal with this problem, new strategies to combat obesity are being investigated, such as the investigation of new bioactive compounds with satiating capacity that can be included in healthy dietary patterns to improve adherence to dietary treatments. Considering this background, the main objective of this research is to assess the effect of daily consumption of protein rich bars accompanied by healthy dietary recommendations on weight loss of overweight/obese adult men and women.

Conditions

Obesity; Weight Loss; Protein

Keywords

Protein; Weight loss; Obesity; Overweight; Satiety

Outcome Measures

Primary Outcomes (6)

• Change of weight from baseline to week 4 (bioimpedance)

  Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).

• Change of weight from baseline to week 8 (bioimpedance)

  Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).

• Change of weight from baseline to week 12 (bioimpedance)

  Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).

• Change of weight from week 4 to week 8 (bioimpedance)

  Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.

  The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 week of intervention) compared to Clinical Investigation Day 3(after 8 weeks of intervention).

• Change of weight from week 4 to week 12 (bioimpedance)

  Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.

  The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 week of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).

• Change of weight from week 8 to week 12 (bioimpedance)

  Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.

  The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 week of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).

Secondary Outcomes (158)

• Change of body fat percentage from baseline to week 8 (bioimpedance)

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).

• Change of body fat percentage from baseline to week 12 (bioimpedance)

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).

• Change of body fat percentage from week 8 to week 12 (bioimpedance)

  The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).

• Change of body fat kilograms from baseline to week 8 (bioimpedance)

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).

• Change of body fat kilograms from baseline to week 12 (bioimpedance)

  The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).

Study Arms (2)

Group receiving dietary recommendations including protein enriched bars .

EXPERIMENTAL

Experimental group will consume two protein enriched bars per day during 12 weeks. First bar will be consumed 45 minutes before lunch and second bar will be consumed 45 minutes before dinner.

Other: Dietary recommendations including protein enriched bars

Group receiving dietary recommendations without protein enriched bars.

PLACEBO COMPARATOR

Placebo group will follow just dietary recommendations during 12 weeks.

Other: Dietary recommendations without protein enriched bars

Interventions

Dietary recommendations including protein enriched bars OTHER

Volunteers allocated in the experimental group will receive dietary recommendations and 2 protein enriched bars per day to be eaten 45 minutes before lunch and dinner.

Group receiving dietary recommendations including protein enriched bars .

Dietary recommendations without protein enriched bars OTHER

Volunteers allocated in the experimental group will receive dietary recommendations.

Group receiving dietary recommendations without protein enriched bars.

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:

• Volunteers with BMI between 24.9 and 34.9 kg/m2.
• Physical examination and vital signs normal or clinically irrelevant to the study.
• Volunteers undergoing pharmacological treatment will be included if the dose is stable for at least 3 months before the start of the study, excluding treatments that alter gastrointestinal function and antidiabetics.
• Subjects must be able to understand and be willing to sign the informed consent, as well as comply with all the procedures and requirements of the study.
• Present a stable weight (+/-3kg) in the last three months before 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 a high alcohol intake, more than 14 units (women) and 20 units (men).
• Women who are breastfeeding or pregnant.
• Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (for example, gastroduodenostomy).
• 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 work night shifts.
• Subjects who follow some type of supplementation that interferes with the study.
• Subjects who are immersed in some treatment for weight loss.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Center for Nutrition Research. University of Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• María Ángeles Zulet, Professor

  Center for Nutrition Research, University of Navarra.

  PRINCIPAL INVESTIGATOR

• Carlos J González Navarro, PhD

  Center for Nutrition Research, University of Navarra.

  STUDY CHAIR

• Fermín I Milagro Yoldi, PhD

  Center for Nutrition Research, University of Navarra.

  STUDY CHAIR

• Idoia Ibero Baraibar, PhD

  Center for Nutrition Research, University of Navarra.

  STUDY CHAIR

• Itziar Abete Goñi, PhD

  Center for Nutrition Research, University of Navarra.

  STUDY CHAIR

• Miguel López Yoldi, PhD

  Center for Nutrition Research, University of Navarra.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: May 10, 2022
• Study Start: January 13, 2022
• Primary Completion: June 24, 2022
• Study Completion: August 30, 2022
• Last Updated: May 12, 2023

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)