The Effect of a Propionate Colon Release Form on ad Libitum Eating and Appetite Perception

NCT04019951 | Completed

• 1 other identifier: 2016-11-28-PROP
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to investigate the effect of a standardized liquid breakfast containing a food grade propionate colon release form on ad libitum eating and appetite perception in healthy overweight humans using a double-blinded, randomized, cross-over study design

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

• Ad-libitum energy intake

  Ad-libitum energy intake will be assessed by giving subjects a choice of an excess of individual pizza slices

  t=210 minutes

Secondary Outcomes (8)

• Subjective ratings of appetite and GI comfort

  Every 30 minutes during an interval of 6 hours

• 24 h food intake

  Food intake is recorded from the time of the start of the ad-libitum food test until 24 hours later

• Serum glucose

  Every 30 minutes during an interval of 6 hours

• Plasma insulin

  Every 30 minutes during an interval of 6 hours

• Plasma ghrelin

  Every 30 minutes during an interval of 6 hours

Study Arms (3)

Propionate (1 g)

EXPERIMENTAL

Participants will receive 1 g of Ca-propionate in a colon-release form. Volunteers will receive the product on visits 2, 3 and 4. Each of the visits will be separated by \> 5 days. Visit 5, the end of study visit, will occur within 5 days of visit 4.

Dietary Supplement: Ca-propionate 1 g

Propionate (3 g)

EXPERIMENTAL

Participants will receive 3 g of Ca-propionate in a colon-release form. Volunteers will receive the product on visits 2, 3 and 4. Each of the visits will be separated by \> 5 days. Visit 5, the end of study visit, will occur within 5 days of visit 4.

Dietary Supplement: Ca-propionate 3 g

Placebo

PLACEBO COMPARATOR

Participants will receive 2.6 g of cellulose in a colon-release form. Volunteers will receive the product on visits 2, 3 and 4. Each of the visits will be separated by \> 5 days. Visit 5, the end of study visit, will occur within 5 days of visit 4.

Dietary Supplement: Placebo

Interventions

Ca-propionate 1 g DIETARY_SUPPLEMENT

1 g of Ca-propionate will be mixed in 203 mL of a standardized liquid breakfast

Propionate (1 g)

Ca-propionate 3 g DIETARY_SUPPLEMENT

3 g of Ca-propionate will be mixed in 203 mL of a standardized liquid breakfast

Propionate (3 g)

Placebo DIETARY_SUPPLEMENT

2.6 g of cellulose will be mixed in 203 mL of a standardized liquid breakfast

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or non-pregnant, non-lactating females, 18-60 years of age
• Body mass index (BMI) ≥25 and \<30 kg/m² at screening.
• Unrestrained eater (Score of ≤11 on the Eating Habits Questionnaire)
• Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
• Subject is willing to abstain from strenuous exercise, and consume alcoholic drinks 24 hours before study days and during study days.
• Willing to refrain from dietary supplement that are known to affect appetite (e.g. some herbal supplements), from prebiotic and probiotic supplements and large amounts of dietary fiber (inulin, metamucil, oat bran, etc) throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
• Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
• Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
• Subject regularly has at least one bowel movement per day

You may not qualify if:

• Smokers
• Haemoglobin measurements of \<120g/L for females and \<130g/L for males (as per WHO criteria for anaemia).
• Fasting serum glucose (above or equal to 7.0mmol/L). AST, ALT, GGT and ALP \>1.8 times upper limit of normal; creatinine \>1.2 times upper limit of normal; fasting triglycerides \>4.0 mmol/L; and electrolytes outside the normal range.
• Known history of AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders.
• Use of medications/dietary supplements known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might: 1) make participation dangerous to the subject or to others, or 2) affect the results as judged by the Investigator.
• History of propionic acidemia.
• Major trauma or surgical event within 3 months of screening.
• Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
• Known intolerance, sensitivity or allergy to any ingredients in the study products.
• Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc).
• Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the average blood pressure measured at screening.
• Change in body weight of \>3.5kg within 4 weeks of the screening visit.
• Presence of any signs or symptoms of an active infection within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment (i.e. antibiotic therapy) has been completed at least 4 weeks prior to each test visit.
• History of cancer in the prior two years, except for non-melanoma skin cancer.
• Recent history (within 12 months of screening) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \> 14 drinks per week (1 drink=12 oz beer, 5 oz wine, or 1.5 oz distilled spirits).

Sponsors & Collaborators

• DSM Nutritional Products, Inc.: lead
• Glycemic Index Laboratories, Inc: collaborator

Study Sites (1)

GI Labs

Toronto, Canada

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas Wolever

  GI Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 15, 2019
• Study Start: January 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: February 1, 2020
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)