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Completed

NCT Number: NCT01806688

Effect of Snacks on Appetite Control

This clinical trial is being conducted to study whether eating certain snacks will reduce your desire to eat and for a longer period of time compared to other snacks. The investigators are testing 2 different snacks. Study #1 will involve eating 2 different seed-like snacks or water. Study #2 will involve eating pita bread with jam, bread with jam or water. The test snack is higher in protein and/or fibre compared to the reference product.

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Key information

Conditions

Healthy Canadians Appetite Control

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

I. H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

About this study

Healthy adults will be recruited to participate in a randomized, controlled, crossover study to investigate whether or not eating snacks made with buckwheat would increase satiety and reduce their energy intake when compared to a comparable snack. Water was included as a non-caloric control. The study consisted of 3 visits and participants would receive a different treatment at each visit. Visits were scheduled at least 7 days apart. Visual analog scales will be used to assess appetite related sensations at 7 time points, fasting, 30 minutes after consuming the snack and then at 30 minute intervals for 180 minutes. Participants will be provided with a lunch and the amount of food consumed will be weighed. I addition, participants will be asked to maintain a food record for the remainder of the day.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index 18-30kg/m2
  • males and non-pregnant or non-lactating females

Exclusion criteria

  • Diagnosis of disease by a medical doctor that requires medical treatment during the study period.
  • Daily tobacco use.
  • Physical Activity Level >1.8.
  • Eat meals at irregular or unusual times.
  • Food allergy, aversion or unwillingness to eat study foods.
  • Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect appetite.
  • Presence of a gastrointestinal disorder.
  • Score >65% on any 1 of the 3 categories of the Three Factor Eating Questionnaire-R18.

Treatment and study plan

gluten-free high protein snack #1

Other

buckwheat groats 30g serving

gluten-free snack with similar energy density but 1/2 the protein as snack #1

Other

32g serving of corn nuts

non-caloric control

Other

water

gluten-free high protein and high fibre snack #2

Other

buckwheat and pinto bean flour pita bread 50g serving

gluten-free snack with similar energy density, but less protein and fibre than snack #2

Other

50g serving of rice bread

Primary outcomes

  1. Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS)

    Time frame: VAS administered pre-snack and then every 30 minutes after the first bite up to 180 minutes for a total of 7 time points.

    Appetite assessment was measured using a VAS questionnaire administered pre-snack and every 30 minutes post snack up to 180 minutes, for a total of 7 time points. The questionnaire included 4 questions (1) How hungry are you? (2) How full are you? (3) How strong is your desire to eat? (4) How much do you think you want to eat right now? Each question was followed by a 10 cm line anchored at the left and right ends by the opposing statements "not at all" and "extremely" for questions 1 and 2, "very weak " and "very strong" for question 3, and "nothing at all" and "a very large amount" for question 4. Participants provided their response to each question by marking a perpendicular line on the 10-cm line to indicate their answer. Scores were determined by measuring the distance in centimeters from the left anchor to the perpendicular line drawn by the participant. VAS scores over time were graphed and AUC was calculated using the trapezoid method.

Secondary outcomes

  1. Number of Calories Consumed Post-snack Until Bedtime

    Time frame: time between snack consumption and bedtime (12 hours)

    Participants were provided with a food diary to record the amount and type of each food and beverage consumed for the remainder of the day. Energy consumed at lunch and the remainder of the day were quantified from food consumed at lunch and the food diary using Food Processor Nutrient Analysis Software.

Other outcomes

  1. Gastrointestinal Side Effects

    Time frame: 24h

    Participants were asked if they noticed any gastrointestinal side effects after having eaten the study food and the results were recorded.

  2. Likeability of Test and Reference Products Based on Sensory Scales

    Time frame: immediately after eating test or reference product

    Likability of the study products was assessed using a 5-point hedonic scale (1 = dislike extremely; 2 = dislike very moderately; 3 = neither like or dislike; 4 = like moderately; 5 = like extremely) for appearance, aroma, flavour, taste, texture and overall liking.

Sponsors and collaborators

Lead sponsor

St. Boniface Hospital

Other

Collaborators

  • Manitoba Agri-Health Research Network

Registry information

Official study title

A Randomized, Controlled, Cross-over Study of the Effect of Snacks on Appetite Control

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 7, 2013
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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