Appetite Suppression Trial With Polydextrose

NCT02064205 | Completed Results

• 2 other identifiers: JZ PDX SatietyWM-01-2014
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Overweight and obesity are a global epidemic, which causes a rapid increase in the frequency of diabetes and cardiovascular diseases. Food ingredients that influence the mechanisms that regulate satiety may play a role in weight management. Suppression of appetite may reduce energy intake, which in return may lead to body weight reduction. This study aims to verify the appetite suppressive effect of polydextrose in comparison to a placebo in normal weight and overweight women.

Conditions

Body Weight; Non-restrained Eaters

Keywords

pre-load; satiety; energy intake; appetite

Outcome Measures

Primary Outcomes (1)

• Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.

  Yogurt with a polydextrose (fiber with satiating effect) is consumed in the morning with breakfast or later in the morning. The satiating effect of the addition of polydextrose is tested on the amount of food consumed with lunch four hours or 1.5h later.

  Four hours or 1.5 hour after consumption of a pre-load at up to day 22

Secondary Outcomes (2)

• The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)

  one day

• Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.

  Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22.

Study Arms (2)

polydextrose or glucose syrup at breakfast

ACTIVE COMPARATOR

Breakfast with pre-load four hours before lunch

Dietary Supplement: 12.5 g polydextrose; Dietary Supplement: glucose syrup

Pre-load with yogurt and polydextrose or glucose later

PLACEBO COMPARATOR

Breakfast without pre-load. Pre-load with yogurt provided 1.5h before lunch.

Dietary Supplement: 12.5 g polydextrose; Dietary Supplement: glucose syrup

Interventions

12.5 g polydextrose DIETARY_SUPPLEMENT

Appetite suppressing supplement is added in yogurt and provided with breakfast (four hours before lunch) or 1.5h before lunch. Also yogurt with control (glucose syrup) is tested for its satiating effect.

Also known as: Litesse®Ultra TM

Pre-load with yogurt and polydextrose or glucose later; polydextrose or glucose syrup at breakfast

glucose syrup DIETARY_SUPPLEMENT

Glucose syrup is used a control product for the polydextrose

Pre-load with yogurt and polydextrose or glucose later; polydextrose or glucose syrup at breakfast

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, female participants aged 20-45 years inclusive
• BMI: 20-30 kg/m2 inclusive
• Written consent regarding participation after full information regarding all details of the study
• Normal Dutch eating habits (consuming mostly three main meals per day; used to eat bread for lunch)

You may not qualify if:

• Pregnancy
• On-going or recent treatment for diabetes, hypertension, coronary heart disease, psychiatric conditions, inflammatory chronic disease - rheumatoid arthritis, Crohn Disease, ulcerous colitis, chronic constipation, eating disorders, or any disease condition which interferes with ADME of the investigational product
• Reported postmenopausal
• Having menstruation problems, e.g. PCOS
• Reported to be on a slimming diet or other dietary treatment (currently or during last two months, like vegetarian diet, lactose restricted diet etc.)
• Aversion towards products (yoghurt) provided in the study
• On-going use of any slimming preparations
• Any kind of dysfunction of digestive tract, food allergy, chronic constipation, recent/actual gastroenteritis
• Restrained eaters (score DEBQ \>3.4)
• Participants consuming more than 23g of dietary fiber per day - P75 according to the Dutch National Food Consumption Survey - (as assessed with a general short questionnaire which gives estimation on the fiber intake. Exact fiber intake will not be calculated)
• Smoker in the last 3 months
• Heavy coffee drinkers (more than 6 cups a day)
• High level of physical activity: Participants who perform more than 3 hours of intense training/sport activity per week (this will not include normal cycling transport)
• Heavy alcohol consumers, no more than 14 units per week (1 unit represents 1 standard glass/portion of alcohol, independent of the type of alcoholic drink).
• Remark:

Sponsors & Collaborators

• W.J. Pasman: lead

Study Sites (1)

QPS

Groningen, 9713AG, Netherlands

Location

Related Publications (1)

• Ibarra A, Olli K, Pasman W, Hendriks H, Alhoniemi E, Raza GS, Herzig KH, Tiihonen K. Effects of polydextrose with breakfast or with a midmorning preload on food intake and other appetite-related parameters in healthy normal-weight and overweight females: An acute, randomized, double-blind, placebo-controlled, and crossover study. Appetite. 2017 Mar 1;110:15-24. doi: 10.1016/j.appet.2016.12.002. Epub 2016 Dec 2.

  PMID: 27916475 DERIVED

MeSH Terms

Conditions

Body Weight

Interventions

polydextrose; High Fructose Corn Syrup

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Sugars; Dietary Carbohydrates; Carbohydrates; Sugars; Nutritive Sweeteners; Sweetening Agents; Flavoring Agents; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: W.J. Pasman, PhD
• Organization: TNO

wilrike.pasman@tno.nl

+31888665129

Study Officials

• Naguib Muhsen, MD

  QPS, The Netherlands

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project Manager Clinical Trials

Model Details: Breakfast meal with or without polydextrose

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 17, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 6, 2022
• Results First Posted: July 27, 2016

Record last verified: 2022-05

Locations

NL (1)