Evaluation of Dose-effect of a New Fermented Food in Healthy Adults

NCT01108419 | Completed

• 1 other identifier: NU327
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the safety and tolerance of a new fermented food versus a control product in healthy adults during the 4-week consumption period.

Conditions

Healthy

Keywords

healthy adults

Outcome Measures

Primary Outcomes (17)

• Effect of 1 bottle/day of test versus control product on adverse events.

  Number of Adverse events, number of AE related to product, number of emergent AE, number of mild/moderate and severe AE, number of serious AE.

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product vital signs.

  Systolic/diastolic blood pressure (mmHg).

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product vital signs.

  Heart rate (bpm).

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product vital signs.

  Weight (kg).

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product vital signs.

  Body mass index (kg/m²).

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product vital signs.

  Temperature (°C).

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product on hematology.

  Hemoglobin (mmol/L).

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product on hematology.

  Hematocrit (L/L).

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product on hematology.

  Red blood cell, white blood cell, platelets (count/L).

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product on glucose and lipids metabolism.

  blood glucose (mmol/L), lipids \[total cholesterol, HDL, LDL, triglycerides\] (mmol/L).

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product on liver function.

  Blood alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase (IU/L).

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product on kidney function.

  Blood creatinin (μmol/L).

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product on thyroid function.

  Blood thyroid stimulating hormone (mU/L).

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product on blood marker of inflammation.

  Blood C-reactive protein (mmol/L)

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product on fecal marker of inflammation.

  Fecal calprotectin (μg/g)

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product on bowel habits.

  Stool frequency and consistency (Bristol Stool Scale from 1 \[hard stools\] to 7 \[watery stools\]).

  During the 4-week period of product consumption.

• Effect of 1 bottle/day of test versus control product on digestive symptoms.

  Frequency of abdominal pain/discomfort, abdominal bloating, flatulence, borborygmi/rumbling.

  During the 4-week period of product consumption.

Secondary Outcomes (40)

• Effect of 1 bottle/day of test versus control product on adverse events.

  During the 4-week follow-up period and the 8-week entire study period.

• Effect of 1 bottle/day of test versus control product vital signs.

  During the 4-week follow-up period and the 8-week entire study period.

• Effect of 1 bottle/day of test versus control product vital signs.

  During the 4-week follow-up period and the 8-week entire study period.

• Effect of 1 bottle/day of test versus control product vital signs.

  During the 4-week follow-up period and the 8-week entire study period.

• Effect of 1 bottle/day of test versus control product vital signs.

  During the 4-week follow-up period and the 8-week entire study period.

Study Arms (4)

1 = Test Product normal dose

ACTIVE COMPARATOR

Fermented dairy product containing probiotics - normal dose

Other: Fermented dairy product

2 = Test Product high dose

ACTIVE COMPARATOR

Fermented dairy product containing probiotics - high dose

Other: Fermented dairy product

3 = Control Product normal dose

SHAM COMPARATOR

Non-fermented dairy product - normal dose

Other: milk-based non-fermented dairy product

4 = Control Product high dose

SHAM COMPARATOR

Non-fermented dairy product - high dose

Other: milk-based non-fermented dairy product

Interventions

Fermented dairy product OTHER

1 = Test Product normal dose; 2 = Test Product high dose

milk-based non-fermented dairy product OTHER

3 = Control Product normal dose; 4 = Control Product high dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects after receiving a full description of the study, provide written informed consent to take part in the study.
• Free-living subject, as evaluated during the clinical examination.
• Male/female subjects aged between 18 to 55 years (bounds included).
• Subjects with a body mass index (BMI) between 18.5 ≤ BMI \< 30kg/m².
• Healthy subjects (as determined by a medical examination)

You may not qualify if:

• Subjects with any allergy (food, respiratory…).
• Subjects that have had any surgery or intervention requiring general anaesthesia in the last 4 weeks.
• Subjects with a history of chronic metabolic or gastrointestinal disease with the exception of appendectomy.
• Subjects with chronic or iatrogenic immunodeficiency (e.g. Chemotherapy, HIV).
• Subjects presenting a severe evolutive or chronic pathology (e.g. cancer,tuberculosis, Crohn's disease, cirrhosis, multiple sclerosis, Type I diabetes…).
• Subject with eating disorders.
• Subjects with cardiac, respiratory (including asthma) or renal insufficiency, cardiomyopathy, valvulopathy and medical history of rheumatic fever.
• Subjects with special medicated diet (for obesity, anorexia, metabolic pathology…).
• For female subjects: pregnancy, breast-feeding or not willing to use/not using an acceptable method of contraception
• Subject, in the Investigator's opinion, should not be randomised.

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead

Study Sites (1)

Harrison Clinical Research Clinical Unit, Hilblestrasse 54

München, D-80636, Germany

Location

MeSH Terms

Interventions

Cultured Milk Products

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Design

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

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: April 22, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2012
• Last Updated: December 23, 2020

Record last verified: 2020-12

Locations

DE (1)