Monitoring Postprandial Glycemia in Fruit Snacks
Status
Completed
Conditions
Blood Glucose
Treatments
Dietary Supplement: Fruit Snack 2
Dietary Supplement: Fruit Snack 3
Dietary Supplement: Fruit snack 1
Dietary Supplement: White Bread
Dietary Supplement: Fruit Snack 4
Details and patient eligibility
About
The goal of this clinical trial is to compare the postprandial glucose and insulin responses after different fruit snack consumption in a healthy population.
Full description
Fruit snacks made from sweetened dried fruits is a source of polyphenols, fiber, and other nutrients. The addition of sugar could aid in the taste, texture, and shelf life of these types of products. Fruit snacks with different levels of sugar were developed to meet various consumer needs. The postprandial glucose response in a healthy population is of interest in this regard.
Mulberry leaf extract has been shown the benefit of blood glucose regulation in multiple studies. This is mainly due to the function of the most predominant iminosugar, 1-deoxynojirimycin (DNJ), in the mulberry leaf extract which acts as α-glucosidase inhibitor. Fruit snacks containing mulberry leaf extract were developed and the postprandial metabolic response against a reference (white bread matched for carbohydrate) will be observed.
Enrollment
20 patients
Sex
All
Ages
18 to 45 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- ≥18 to ≤45 years of age at visit 1.
- BMI ≥18.5 and <30.0 kg/m2 at visit 1.
- Fasting capillary glucose <100 mg/dL at visit 1.
- Willing to avoid consuming high-polyphenol containing foods (Appendix 2) for 48 h prior to each test visit.
- Willing to abstain from alcohol consumption for 24 hours prior to each study visit.
- Non-user of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1, with no plans to begin use during the study period.
- Willing to maintain habitual physical activity level throughout the duration of the study.
- Willing to maintain habitual dietary pattern throughout the duration of the study, including stable intake of current vitamins, minerals, supplements and medications not interfering with study outcomes.
- Score of 7 to 10 on the Vein Access Scale at visit 1 (Appendix provided for further checking).
- No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history.
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Exclusion criteria
- History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, or neurological disorders that may affect the subject's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit 1 (3 repeated measurements will be taken after subjects sit quietly for at least 5 mins. Each measurement will be separated by at least 2 minutes. The average of the last two measurements will be used).
- Unstable use (initiation or change in dose) within 30 days of visit 1 of antihypertensive medications.
- Unstable use (initiation or change in dose) within 30 days of visit 1 of thyroid hormone replacement medications.
- Use of medications or supplements that may influence carbohydrate metabolism within 30 days of visit 1.
- Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian) at the discretion of the Clinical Investigator.
- Weight loss or gain >4.5 kg in the 2 months prior to visit 1.
- Currently, or planning to be, on a weight loss regimen during the study.
- Use of weight loss medication within 90 d of visit 1.
- History of gastrointestinal surgery for weight reducing purposes.
- History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
- Known allergy or sensitivity to any ingredients or potential allergens contained in the study product.
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- History of any major trauma or major surgical event within 2 months of visit 1.
- Blood donation >450 mL within 8 weeks of visit 2 or plans to donate blood or plasma during the study period.
- Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential with unstable use (initiation or change in dose) within 30 days of visit 1) of sex hormones for contraception.
- Recent history of (within 12 months of screening; visit 1) 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 1½ oz distilled spirits).
- Exposed to any non-registered drug product within 30 days prior to visit 1.
- Any condition the Investigator believes would interfere with the subject's ability to provide informed consent or comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Quadruple Blind
20 participants in 5 patient groups
First product order: order not stated to protect study blinding
Experimental group
Description:
Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence
Treatment:
Dietary Supplement: Fruit Snack 4
Dietary Supplement: White Bread
Dietary Supplement: Fruit Snack 3
Dietary Supplement: Fruit Snack 2
Dietary Supplement: Fruit snack 1
Second product order: order not stated to protect study blinding
Experimental group
Description:
Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence
Treatment:
Dietary Supplement: Fruit Snack 4
Dietary Supplement: White Bread
Dietary Supplement: Fruit Snack 3
Dietary Supplement: Fruit Snack 2
Dietary Supplement: Fruit snack 1
Third product order: order not stated to protect study blinding
Experimental group
Description:
Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence
Treatment:
Dietary Supplement: Fruit Snack 4
Dietary Supplement: White Bread
Dietary Supplement: Fruit Snack 3
Dietary Supplement: Fruit Snack 2
Dietary Supplement: Fruit snack 1
Fourth product order: order not stated to protect study blinding
Experimental group
Description:
Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence
Treatment:
Dietary Supplement: Fruit Snack 4
Dietary Supplement: White Bread
Dietary Supplement: Fruit Snack 3
Dietary Supplement: Fruit Snack 2
Dietary Supplement: Fruit snack 1
Fifth product order: order not stated to protect study blinding
Experimental group
Description:
Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence
Treatment:
Dietary Supplement: Fruit Snack 4
Dietary Supplement: White Bread
Dietary Supplement: Fruit Snack 3
Dietary Supplement: Fruit Snack 2
Dietary Supplement: Fruit snack 1
Trial contacts and locations
1
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Central trial contact
Junnan Gu, PhD
Data sourced from clinicaltrials.gov
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