Effect of Acute Intake of Meals Containing Higher vs. Lower Energy From Protein on DIT

NCT06494449 | Completed

• 1 other identifier: MB-2412
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to assess the effects of acute intake of mixed meals containing higher vs. lower energy from protein on diet induced thermogenesis (DIT) in adults with overweight or obesity.

Conditions

Healthy; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Diet Induced Thermogenesis (DIT) AUC

  Change in DIT assessed as the area under the curve (AUC)

  Pre-consumption (0 minutes) to 300 minutes

Secondary Outcomes (4)

• DIT niAUC

  Pre-consumption (0 minutes) to 300 minutes

• Carbohydrate oxidation

  Pre-consumption (0 minutes) to 300 minutes

• Fat oxidation

  Pre-consumption (0 minutes) to 300 minutes

• Respiratory Exchange Ratio (RER)

  Pre-consumption (0 minutes) to 300 minutes

Study Arms (2)

Higher protein

EXPERIMENTAL

Other: Higher protein

Lower protein

ACTIVE COMPARATOR

Other: Lower protein

Interventions

Higher protein OTHER

An acute mixed meal containing higher protein

Higher protein

Lower protein OTHER

An acute mixed meal containing lower protein

Lower protein

Eligibility Criteria

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

You may qualify if:

• Male or female 18 to 55 years of age, inclusive. There will be approximately equal numbers of men and women within the groups with overweight/obesity and normal weight.
• Individual has BMI of 18.5 to 24.9 kg/m2 or 27.0 to 34.9 kg/m2, inclusive.
• Individual has a REE (measured at the screening visit using indirect calorimetry) between 1,250 and 2,250 kcals/d.
• For premenopausal women, individual has a history of regular menstrual cycles (21-35 d per cycle) for at least 3 months prior to visit 1.
• Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
• Individual is willing and able to undergo the scheduled study procedures.
• Individual understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

You may not qualify if:

• Individual has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
• Individual has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results. Health conditions may include history or presence of clinically important cardiac, renal, hepatic, endocrine (i.e., diabetes), pulmonary, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
• Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1.
• Use of hemp/marijuana products within 12 months of visit 1. Occasional use (e.g., once or twice a month) within 12 months of visit 1 is allowed but requires at least a 14-d washout prior to visit 1 and the participant must be willing to refrain from use during the study.
• Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
• Unstable use (initiation or change in dose) within 30 d of visit 1 of thyroid hormone replacement medications.
• Unstable use (initiation or change in dose) within 30 d of visit 1 of sex hormones for contraception.
• Use of medications or supplements that may influence carbohydrate or fat metabolism, including but not limited to hypoglycemic medications and systemic (intravenous, intramuscular, or oral) or ≥1500 µg/d (topical, inhaled, intranasal, or dermal) corticosteroids within 30 d of visit 1.
• Use of any weight loss medication within 90 d of visit 1.
• Use of medications or supplements that may influence heart rate, including but not limited to stimulant medications (e.g., amphetamines, methylphenidates, etc.) within 30 d of visit 1.
• Individual has a history of cancer in the prior 5 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
• Individual has had a weight change of ± 4.5 kg (10 lbs) in the previous 3 months.
• Individual has extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian).
• Individual is actively following a weight loss diet (even if maintaining body weight).
• Individual habitually consumes a diet with \<10% or ≥ 20% of energy from protein.

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• General Mills: collaborator

Study Sites (1)

Biofortis Clinical Research

Addison, Illinois, 60101, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Kevin C. Maki, PhD

  MB Clinical Research & Consulting, LLC

  STUDY DIRECTOR

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: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: August 8, 2024
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: April 6, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)