How low do you need to go? Comparing symptoms of diet induction and mood with outcomes from diets containing differing levels of carbohydrate restriction.

Not Applicable

Completed

• Conditions: obesity; diabetes; cardiovascular disease; Diet and Nutrition - Obesity; Metabolic and Endocrine - Diabetes; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12617000421336
• Lead Sponsor: AUT University

Brief Summary

Key findings: • Reduced carbohydrate diets have a positive effect on markers of health • Low-carbohydrate diets were easily adhered to over a 12-week period • There were significant and clinically meaningful improvements in weight, waist-height ratio, HDL-c and TG. • All diets were functionally ketogenic based on the mean level of BOHB achieved per group • A 5% carbohydrate allocation is consistently ketogenic for almost all participants, but a low-carbohydrate intervention of 25% or 15% carbohydrate can be ketogenic for some people. • Symptoms of carbohydrate withdrawal increased concomitant to the magnitude of carbohydrate restriction, but the changes from baseline were small, and there was no significant difference between intervention groups. • Mean reported symptoms differed by less than 2 out of a possible score of 48 (range between groups; 3.00 - 4.95), and there is little clinically meaningful difference in adverse effects of carbohydrate withdrawal between diets differing in carbohydrate restriction. • The ‘keto-flu’ is limited to the symptoms of breath expression of ketone bodies and a minor increase in muscle weakness. • Mood improved significantly from baseline as a result of all dietary interventions but did not differ significantly between groups

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-24
• Study Completion: 2017-12-10
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

Non-obese, non-diabetic, between the ages of 25 and 49.

Exclusion Criteria

BMI <19 or >30, diagnosed metabolic condition such as diabetes, or cardiovascular disease, chronic kidney or liver disease. Pregnancy or breastfeeding. Habitual intake of >40% calories from carbohydrate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mood from baseline (POMS-SF)[12 weeks];Change in carbohydrate withdrawal questionnaire (Symptoms-Q) from baseline[12 weeks ]

Secondary Outcome Measures

Name	Time	Method
Change in triglyceride to HDL cholesterol ratio from serum assay[Twelve weeks];Change in HbA1c from serum assay [Twelve weeks];Change in total cholesterol to HDL ratio from serum assay, [twelve weeks];change in body fat percentage - measured by skinfold callipers at baseline and completion[twelve weeks];Change in waist to hip ratio as measured by tape measure at baseline and completion [twelve weeks];Change in serum urate (from serum assay)[twelve weeks];Change in c-reactive protein as measured y serum assay[twelve weeks]